Surgical instrument with multiple program responses during a firing motion

ABSTRACT

A surgical instrument. The surgical instrument includes an elongated channel configured to support a staple cartridge, an anvil pivotably connected to the elongated channel, a knife mechanically coupled to the staple cartridge, an electric motor and a control circuit electrically connected to the electric motor. The control circuit is configured to change a firing motion of the surgical instrument based on a combination of events.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 15/130,571, entitledSURGICAL INSTRUMENT WITH MULTIPLE PROGRAM RESPONSES DURING A FIRINGMOTION, filed Apr. 15, 2016, now U.S. Patent Application Publication No.2017/0296183, the entire disclosure of which is hereby incorporated byreference herein.

TECHNICAL FIELD

The present disclosure relates to surgical instruments and, in variouscircumstances, to surgical stapling and cutting instruments and staplecartridges therefor that are designed to staple and cut tissue.

BACKGROUND

In a motorized surgical stapling and cutting instrument it would behelpful to have change the firing parameters (speed of firing, timing ofa pause in firing, duration of a firing pause, clamp pressure, etc.) toaffect staple formation based on real-time (or continuous) determinationof defect density. While several devices have been made and used, it isbelieved that no one prior to the inventors has made or used the devicedescribed in the appended claims.

BRIEF SUMMARY

In some aspects, a surgical instrument is provided. The surgicalinstrument comprises an elongated channel configured to support a staplecartridge; an anvil pivotably connected to the elongated channel; aclosure tube mechanically coupled to the anvil; an electric motor; and acontrol circuit electrically connected to the electric motor, whereinthe control circuit is configured to change a closing motion of thesurgical instrument based on a combination of events.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects and featuresdescribed above, further aspects and features will become apparent byreference to the drawings and the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the aspects described herein are set forth withparticularity in the appended claims. The aspects, however, both as toorganization and methods of operation may be better understood byreference to the following description, taken in conjunction with theaccompanying drawings as follows.

FIG. 1 is a perspective view of a surgical instrument that has aninterchangeable shaft assembly operably coupled thereto in accordancewith one or more aspects of the present disclosure.

FIG. 2 is an exploded assembly view of the interchangeable shaftassembly and surgical instrument of FIG. 1 in accordance with one ormore aspects of the present disclosure.

FIG. 3 is another exploded assembly view showing portions of theinterchangeable shaft assembly and surgical instrument of FIGS. 1 and 2in accordance with one or more aspects of the present disclosure.

FIG. 4 is an exploded assembly view of a portion of the surgicalinstrument of FIGS. 1-3 in accordance with one or more aspects of thepresent disclosure.

FIG. 5 is a cross-sectional side view of a portion of the surgicalinstrument of FIG. 4 with the firing trigger in a fully actuatedposition in accordance with one or more aspects of the presentdisclosure.

FIG. 6 is another cross-sectional view of a portion of the surgicalinstrument of FIG. 5 with the firing trigger in an unactuated positionin accordance with one or more aspects of the present disclosure.

FIG. 7 is another exploded assembly view of portions of theinterchangeable shaft assembly of FIG. 7 in accordance with one or moreaspects of the present disclosure.

FIG. 8 is a cross-sectional view of a portion of the interchangeableshaft assembly of FIGS. 7-9, in accordance with one or more aspects ofthe present disclosure.

FIG. 9 is another perspective view of the portion of an interchangeableshaft assembly with the switch drum mounted thereon in accordance withone or more aspects of the present disclosure.

FIG. 10 is a perspective view of a portion of the interchangeable shaftassembly of FIG. 11 operably coupled to a portion of the surgicalinstrument of FIG. 1 illustrated with the closure trigger thereof in anunactuated position in accordance with one or more aspects of thepresent disclosure.

FIG. 11 is a right side elevational view of the interchangeable shaftassembly and surgical instrument of FIG.10 in accordance with one ormore aspects of the present disclosure.

FIG. 12 is a perspective view of a portion of the interchangeable shaftassembly of FIG. 11 operably coupled to a portion of the surgicalinstrument of FIG. 1 illustrated with the closure trigger thereof in anactuated position and a firing trigger thereof in an unactuated positionin accordance with one or more aspects of the present disclosure.

FIG. 13 is a right side elevational view of the interchangeable shaftassembly operably coupled to a portion of the surgical instrument ofFIG. 1 illustrated with the closure trigger thereof in an actuatedposition and the firing trigger thereof in an actuated position inaccordance with one or more aspects of the present disclosure.

FIG. 14 is an exploded view of one aspect of an end effector of thesurgical instrument of FIG. 1 in accordance with one or more aspects ofthe present disclosure.

FIG. 15 is a schematic of a system for powering down an electricalconnector of a surgical instrument handle when a shaft assembly is notcoupled thereto in accordance with one or more aspects of the presentdisclosure.

FIGS. 16A-16B is a circuit diagram of the surgical instrument of FIG. 1spanning two drawings sheets in accordance with one or more aspects ofthe present disclosure

FIGS. 17A-17B, is a circuit diagram of the surgical instrument of FIG. 1in accordance with one or more aspects of the present disclosure.

FIG. 18 is a block diagram the surgical instrument of FIG. 1illustrating interfaces between the handle assembly and the powerassembly and between the handle assembly and the interchangeable shaftassembly in accordance with one or more aspects of the presentdisclosure.

FIG. 19 illustrates a logic diagram of a system for evaluating sharpnessof a cutting edge of a surgical instrument in accordance with one ormore aspects of the present disclosure.

FIG. 20 illustrates a logic diagram of a system for determining theforces applied against a cutting edge of a surgical instrument by asharpness testing member at various sharpness levels in accordance withone or more aspects of the present disclosure.

FIG. 21 illustrates one aspect of a process for adapting operations of asurgical instrument in accordance with one or more aspects of thepresent disclosure.

FIG. 22A depicts an example end-effector of a medical device surroundingtissue in accordance with one or more aspects of the present disclosure.

FIG. 22B depicts an example end-effector of a medical device compressingtissue in accordance with one or more aspects of the present disclosure.

FIG. 23A depicts example forces exerted by an end-effector of a medicaldevice compressing tissue in accordance with one or more aspects of thepresent disclosure.

FIG. 23B also depicts example forces exerted by an end-effector of amedical device compressing tissue in accordance with one or more aspectsof the present disclosure.

FIG. 24 depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure.

FIG. 25 also depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure.

FIG. 26 also depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure.

FIG. 27 depicts an example end-effector channel frame in accordance withone or more aspects of the present disclosure.

FIG. 28 depicts an example end-effector in accordance with one or moreaspects of the present disclosure.

FIG. 29 also depicts an example end-effector channel frame in accordancewith one or more aspects of the present disclosure.

FIG. 30 also depicts an example end-effector channel frame in accordancewith one or more aspects of the present disclosure.

FIG. 31 also depicts an example end-effector channel frame in accordancewith one or more aspects of the present disclosure.

FIG. 32 depicts an example electrode in accordance with one or moreaspects of the present disclosure.

FIG. 33 depicts an example electrode wiring system in accordance withone or more aspects of the present disclosure.

FIG. 34 also depicts an example end-effector channel frame in accordancewith one or more aspects of the present disclosure.

FIG. 35 is an example circuit diagram in accordance with one or moreaspects of the present disclosure.

FIG. 36 is also an example circuit diagram in accordance with one ormore aspects of the present disclosure.

FIG. 37 is also an example circuit diagram in accordance with one ormore aspects of the present disclosure.

FIG. 38 is a perspective view of a surgical instrument with anarticulable, interchangeable shaft in accordance with one or moreaspects of the present disclosure.

FIG. 39 is a side view of the tip of the surgical instrument shown inFIG. 38 in accordance with one or more aspects of the presentdisclosure.

FIG. 40 illustrates a cross-sectional view of an end effector of asurgical instrument in accordance with one or more aspects of thepresent disclosure.

FIG. 41 illustrates a logic diagram of a feedback system in accordancewith one or more aspects of the present disclosure.

FIG. 42 illustrates a logic diagram of a feedback system in accordancewith one or more aspects of the present disclosure.

FIG. 43 is a diagram of a smart sensor component in accordance with anaspect the present disclosure.

FIG. 44 illustrates one aspect of a circuit configured to convertsignals from a first sensor and a plurality of secondary sensors intodigital signals receivable by a processor in accordance with one or moreaspects of the present disclosure.

FIG. 45 illustrates one aspect of an exploded view of a staple cartridgethat comprises a flex cable connected to a magnetic field sensor andprocessor in accordance with one or more aspects of the presentdisclosure.

FIG. 46 illustrates the end effector shown in FIG. 46 with a flex cableand without the shaft assembly in accordance with one or more aspects ofthe present disclosure.

FIGS. 47 and 48 illustrate an elongated channel portion of an endeffector without the anvil or the staple cartridge, to illustrate howthe flex cable shown in FIG. 46 can be seated within the elongatedchannel in accordance with one or more aspects of the presentdisclosure.

FIG. 49 illustrates a flex cable, shown in FIGS. 46-48, alone inaccordance with one or more aspects of the present disclosure.

FIG. 50 illustrates a close up view of the elongated channel shown inFIGS. 114 and 115 with a staple cartridge coupled thereto in accordancewith one or more aspects of the present disclosure.

FIGS. 51 and 52 illustrate one aspect of a distal sensor plug where FIG.51 illustrates a cutaway view of the distal sensor plug and FIG. 52further illustrates the magnetic field sensor and the processoroperatively coupled to the flex board such that they are capable ofcommunicating in accordance with one or more aspects of the presentdisclosure.

FIG. 53 illustrates an aspect of an end effector with a flex cableoperable to provide power to sensors and electronics in the distal tipof the anvil portion in accordance with one or more aspects of thepresent disclosure.

FIG. 54 is a perspective view of an end effector of a surgical staplinginstrument including a cartridge channel, a staple cartridge positionedin the cartridge channel, and an anvil in accordance with one or moreaspects of the present disclosure.

FIG. 55 is a cross-sectional elevational view of the surgical staplinginstrument of FIG. 134 illustrating a sled and a firing member in anunfired position in accordance with one or more aspects of the presentdisclosure.

FIG. 56 is a detail view depicting the sled of FIG. 55 in a partiallyadvanced position and the firing member in its unfired position inaccordance with one or more aspects of the present disclosure.

FIG. 57 illustrates one aspect of an end effector comprising a firstsensor and a second sensor in accordance with one or more aspects of thepresent disclosure.

FIG. 58 is a logic diagram illustrating one aspect of a process fordetermining the thickness of a tissue section clamped between an anviland a staple cartridge of an end effector in accordance with one or moreaspects of the present disclosure.

FIG. 59 is a logic diagram illustrating one aspect of a process fordetermining the thickness of a tissue section clamped between the anviland the staple cartridge of the end effector in accordance with one ormore aspects of the present disclosure.

FIG. 60 illustrates one aspect of an end effector comprising a firstsensor and a second sensor in accordance with one or more aspects of thepresent disclosure.

FIG. 61 illustrates one aspect of an end effector comprising a firstsensor and a plurality of second sensors in accordance with one or moreaspects of the present disclosure.

FIG. 62 illustrates one aspect of an end effector comprising a pluralityof sensors in accordance with one or more aspects of the presentdisclosure.

FIG. 63 is a logic diagram illustrating one aspect of a process fordetermining one or more tissue properties based on a plurality ofsensors in accordance with one or more aspects of the presentdisclosure.

FIG. 64 illustrates one aspect of an end effector comprising a pluralityof sensors coupled to a jaw member in accordance with one or moreaspects of the present disclosure.

FIG. 65 illustrates one aspect of a staple cartridge comprising aplurality of sensors formed integrally therein in accordance with one ormore aspects of the present disclosure.

FIG. 66 is a logic diagram illustrating one aspect of a process fordetermining one or more parameters of a tissue section clamped within anend effector in accordance with one or more aspects of the presentdisclosure.

FIG. 67 illustrates one aspect of an end effector comprising a sensorcomprising a specific sampling rate to limit or eliminate false signalsin accordance with one or more aspects of the present disclosure.

FIG. 68 is a logic diagram illustrating one aspect of a process forgenerating a thickness measurement for a tissue section located betweenan anvil and a staple cartridge of an end effector in accordance withone or more aspects of the present disclosure.

FIGS. 69A-69B illustrate one aspect of an end effector comprising apressure sensor in accordance with one or more aspects of the presentdisclosure.

FIG. 70 illustrates one aspect of an end effector comprising a secondsensor located between a staple cartridge and a jaw member in accordancewith one or more aspects of the present disclosure.

FIG. 71 is a logic diagram illustrating one aspect of a process fordetermining the thickness of a tissue section clamped in an endeffector, according to FIGS. 69A-69B or FIG. 70 in accordance with oneor more aspects of the present disclosure.

FIG. 72 illustrates one aspect of an end effector comprising a pluralityof second sensors located between a staple cartridge and an elongatedchannel in accordance with one or more aspects of the presentdisclosure.

FIGS. 73A and 73B further illustrate the effect of a full versus partialbite of tissue in accordance with one or more aspects of the presentdisclosure.

FIG. 74 illustrates an aspect of an end effector that is configured todetermine the location of a cutting member or knife in accordance withone or more aspects of the present disclosure.

FIG. 75 illustrates an example of the code strip in operation with redLEDs and an infrared LED in accordance with one or more aspects of thepresent disclosure.

FIG. 76 illustrates a partial perspective view of an end effector of asurgical instrument comprising a staple cartridge in accordance with oneor more aspects of the present disclosure.

FIG. 77 illustrates an elevational view of a portion of the end effectorof FIG. 76 in accordance with one or more aspects of the presentdisclosure.

FIG. 78 illustrates a logic diagram of a module of the surgicalinstrument of FIG. 76 in accordance with one or more aspects of thepresent disclosure.

FIG. 79 illustrates a partial view of a cutting edge, an optical sensor,and a light source of the surgical instrument of FIG. 76 in accordancewith one or more aspects of the present disclosure.

FIG. 80 illustrates a partial view of a cutting edge, an optical sensor,and a light source of the surgical instrument of FIG. 76 in accordancewith one or more aspects of the present disclosure.

FIG. 81 illustrates a partial view of a cutting edge, an optical sensor,and a light source of the surgical instrument of FIG. 76 in accordancewith one or more aspects of the present disclosure.

FIG. 82 illustrates a partial view of a cutting edge, optical sensors,and light sources of the surgical instrument of FIG. 76 in accordancewith one or more aspects of the present disclosure.

FIG. 83 illustrates a partial view of a cutting edge, an optical sensor,and a light source of the surgical instrument of FIG. 76 in accordancewith one or more aspects of the present disclosure.

FIG. 84 illustrates a perspective view of a staple cartridge including asharpness testing member in accordance with one or more aspects of thepresent disclosure.

FIG. 85 illustrates a logic diagram of a module of a surgical instrumentin accordance with one or more aspects of the present disclosure.

FIG. 86 illustrates a logic diagram of a module of a surgical instrumentin accordance with one or more aspects of the present disclosure.

FIG. 87 illustrates a logic diagram outlining a method for evaluatingsharpness of a cutting edge of a surgical instrument in accordance withone or more aspects of the present disclosure.

FIG. 88 illustrates a flow chart outlining a method for determiningwhether a cutting edge of a surgical instrument is sufficiently sharp totransect tissue captured by the surgical instrument in accordance withone or more aspects of the present disclosure.

FIG. 89 illustrates a table showing predefined tissue thicknesses andcorresponding predefined threshold forces in accordance with one or moreaspects of the present disclosure.

FIG. 90 illustrates a logic diagram of a common controller for use witha plurality of motors of a surgical instrument in accordance with one ormore aspects of the present disclosure.

FIG. 91 illustrates a partial elevational view of the handle of thesurgical instrument with a removed outer casing in accordance with oneor more aspects of the present disclosure.

FIG. 92 illustrates a partial elevational view of the surgicalinstrument with a removed outer casing in accordance with one or moreaspects of the present disclosure.

FIG. 93A illustrates a side angle view of an end effector with the anvilin a closed position, illustrating one located on either side of thecartridge deck in accordance with one or more aspects of the presentdisclosure.

FIG. 93B illustrates a three-quarter angle view of the end effector withthe anvil in an open position, and one LED located on either side of thecartridge deck in accordance with one or more aspects of the presentdisclosure.

FIG. 94A illustrates a side angle view of an end effector with the anvilin a closed position and a plurality of LEDs located on either side ofthe cartridge deck in accordance with one or more aspects of the presentdisclosure.

FIG. 94B illustrates a three-quarter angle view of the end effector withthe anvil in an open position, and a plurality of LEDs located on eitherside of the cartridge deck in accordance with one or more aspects of thepresent disclosure.

FIG. 95A illustrates a side angle view of an end effector with the anvilin a closed position, and a plurality of LEDs from the proximal to thedistal end of the staple cartridge, on either side of the cartridge deckin accordance with one or more aspects of the present disclosure.

FIG. 95B illustrates a three-quarter angle view of the end effector withthe anvil in an open position, illustrating a plurality of LEDs from theproximal to the distal end of the staple cartridge, and on either sideof the cartridge deck in accordance with one or more aspects of thepresent disclosure.

FIG. 96 is a circuit diagram of an example power assembly of a surgicalinstrument in accordance with one or more aspects of the presentdisclosure.

FIG. 97 is a circuit diagram of an example power assembly of a surgicalinstrument in accordance with one or more aspects of the presentdisclosure.

FIG. 98 is a schematic block diagram of a control system of a surgicalinstrument in accordance with one or more aspects of the presentdisclosure.

FIG. 99 is a schematic block diagram of a control system of a surgicalinstrument in accordance with one or more aspects of the presentdisclosure.

FIG. 100 is a schematic diagram of an absolute positioning systemcomprising a controlled motor drive circuit arrangement comprising asensor arrangement in accordance with one or more aspects of the presentdisclosure.

FIG. 101 is a detail perspective view of a sensor arrangement for anabsolute positioning system in accordance with one or more aspects ofthe present disclosure.

FIG. 102 is an exploded perspective view of the sensor arrangement foran absolute positioning system showing a control circuit board assemblyand the relative alignment of the elements of the sensor arrangement inaccordance with one or more aspects of the present disclosure.

FIG. 103 is a schematic diagram of one aspect of a position sensor foran absolute positioning system comprising a magnetic rotary absolutepositioning system in accordance with one or more aspects of the presentdisclosure.

FIG. 104 is a schematic illustrating a system for controlling the speedof a motor and/or the speed of a drivable member of a surgicalinstrument in accordance with one or more aspects of the presentdisclosure.

FIG. 105 is a schematic illustrating another system for controlling thespeed of a motor and/or the speed of a drivable member of a surgicalinstrument in accordance with one or more aspects of the presentdisclosure.

FIG. 106 illustrates a perspective view of a surgical instrumentaccording to various aspects in accordance with one or more aspects ofthe present disclosure.

FIG. 107 illustrates a method of controlling a closing motion of thesurgical instrument of FIG. 106 according to various aspects inaccordance with one or more aspects of the present disclosure.

FIG. 108 illustrates an example graph showing a curve representative ofa closing force signal over time for various aspects of the surgicalinstrument of FIG. 106 in accordance with one or more aspects of thepresent disclosure.

FIG. 109 illustrates an example graph showing a curve representative ofa firing force signal over time and a curve representative of a knifevelocity over time for various aspects of the surgical instrument ofFIG. 106 in accordance with one or more aspects of the presentdisclosure.

FIG. 110 illustrates an example graph showing a curve representative ofa firing force signal and a knife position over time for various aspectsof the surgical instrument of FIG. 106 in accordance with one or moreaspects of the present disclosure.

FIG. 111 illustrates an example graph showing a curve representative ofa firing force signal and a curve representative of a knife velocityover time for various aspects of the surgical instrument of FIG. 106 inaccordance with one or more aspects of the present disclosure.

FIG. 112 illustrates an example graph showing a curve representative ofa closing force FC over time t for various aspects of the surgicalinstrument of FIG. 106 and a curve representative of a firing force FFover time t of the surgical instrument of FIG. 106 in accordance withone or more aspects of the present disclosure.

FIG. 113 illustrates various aspects of a direction sensor of thesurgical instrument of FIG. 106 in accordance with one or more aspectsof the present disclosure.

FIG. 114 illustrates various aspects of a direction sensor of thesurgical instrument of FIG. 106 in accordance with one or more aspectsof the present disclosure.

FIG. 115 illustrates a perspective view of another surgical instrumentin accordance with one or more aspects of the present disclosure.

FIG. 116 illustrates a method of controlling a firing motion of thesurgical instrument of FIG. 115 in accordance with one or more aspectsof the present disclosure.

FIG. 117 illustrates an example graph showing a curve representative ofa firing force signal over time for the surgical instrument of FIG. 115in accordance with one or more aspects of the present disclosure.

FIG. 118 illustrates another example graph showing a curverepresentative of a firing force signal over time for the surgicalinstrument of FIG. 115 in accordance with one or more aspects of thepresent disclosure.

FIG. 119 illustrates an example graph showing a curve representative ofa closing force FC over time t for various aspects of the surgicalinstrument and a curve representative of a firing force FF over time tfor the surgical instrument of FIG. 115 in accordance with one or moreaspects of the present disclosure.

FIG. 120 illustrates an example graph showing a curve representative ofa firing force signal and a knife position over time and a curverepresentative of a knife velocity over time for the surgical instrumentof FIG. 115 in accordance with one or more aspects of the presentdisclosure.

FIG. 121 illustrates a perspective view of another surgical instrumentin accordance with one or more aspects of the present disclosure.

FIG. 122 illustrates a method of controlling a firing motion of thesurgical instrument of FIG. 121 in accordance with one or more aspectsof the present disclosure.

FIG. 123 illustrates an example graph showing a curve representative ofa firing force signal over time and a knife position over time and acurve representative of a knife velocity over time for the surgicalinstrument of FIG. 121 in accordance with one or more aspects of thepresent disclosure.

FIG. 124 illustrates an example graph showing the rate of closure of thejaws for the surgical instrument of FIG. 121 in accordance with one ormore aspects of the present disclosure.

FIG. 125 illustrates a perspective view of another surgical instrumentin accordance with one or more aspects of the present disclosure.

FIGS. 126A and 126B illustrate a method of controlling a firing motionof the surgical instrument of FIG. 125 in accordance with one or moreaspects of the present disclosure.

FIG. 127 illustrates an example graph showing a curve representative ofa firing force signal over time and a knife position over time and acurve representative of a knife velocity over time for various aspectsof the surgical instrument of FIG. 125 in accordance with one or moreaspects of the present disclosure.

DETAILED DESCRIPTION

Applicant of the present application owns the following patentapplications that were filed on Apr. 15, 2016 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 15/130,575, entitled STAPLE FORMATIONDETECTION MECHANISMS, now U.S. Patent Application Publication No.2017/0296189;

U.S. patent application Ser. No. 15/130,582, entitled SURGICALINSTRUMENT WITH DETECTION SENSORS, now U.S. Patent ApplicationPublication No. 2017/0296178;

U.S. patent application Ser. No. 15/130,588, entitled SURGICALINSTRUMENT WITH IMPROVED STOP/START CONTROL DURING A FIRING MOTION, nowU.S. Patent Application Publication No. 2017/0296179;

U.S. patent application Ser. No. 15/130,595, entitled SURGICALINSTRUMENT WITH ADJUSTABLE STOP/START CONTROL DURING A FIRING MOTION,now U.S. Patent Application Publication No. 2017/0296180;

U.S. patent application Ser. No. 15/130,566, entitled SURGICALINSTRUMENT WITH MULTIPLE PROGRAM RESPONSES DURING A FIRING MOTION, nowU.S. Patent Application Publication No. 2017/0296177;

U.S. patent application Ser. No. 15/130,581, entitled MODULAR SURGICALINSTRUMENT WITH CONFIGURABLE OPERATING MODE, now U.S. Patent ApplicationPublication No. 2017/0296184;

U.S. patent application Ser. No. 15/130,590, entitled SYSTEMS ANDMETHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT, nowU.S. Patent Application Publication No. 2017/0296213; and

U.S. patent application Ser. No. 15/130,596, entitled SYSTEMS ANDMETHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT, nowU.S. Patent Application Publication No. 2017/0296169.

The present disclosure provides an overall understanding of theprinciples of the structure, function, manufacture, and use of thedevices and methods disclosed herein. One or more examples of theseaspects are illustrated in the accompanying drawings. Those of ordinaryskill in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting examples. The features illustrated ordescribed in connection with one example may be combined with thefeatures of other examples. Such modifications and variations areintended to be included within the scope of the present disclosure.

Various example devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, theperson of ordinary skill in the art will readily appreciate that thevarious methods and devices disclosed herein can be used in numeroussurgical procedures and applications including, for example, inconnection with open surgical procedures. As the present DetailedDescription proceeds, those of ordinary skill in the art will furtherappreciate that the various instruments disclosed herein can be insertedinto a body in any way, such as through a natural orifice, through anincision or puncture hole formed in tissue, etc. The working portions orend effector portions of the instruments can be inserted directly into apatient's body or can be inserted through an access device that has aworking channel through which the end effector and elongated shaft of asurgical instrument can be advanced.

In one aspect, the present disclosure provides a motorized surgicalstapling and cutting instrument configured to detect staple malformationas a trigger for making firing speed adjustments. In one aspect, thepresent disclosure provides a motorized surgical stapling and cuttinginstrument configured to change the firing parameters (speed of firing,timing of a pause in firing, duration of a firing pause, clamp pressure,etc.) to affect staple form based on real-time (or continuous)determination of defect density. In one aspect, the present disclosureprovides a motorized surgical stapling and cutting instrument configuredto obtain information from sensor arrays and analyze the information bycomputing the “defect” density at any location along the staple line.“Defect density” can be analyzed as a running number along the entiretyof the staple line. Alternatively, the staple line integrity (SLI) maybe determined at each opportunity along the length of the staple line.The defect density can be used to inform the surgeon of possible issuesprior to unclamping the device. If certain thresholds of defect densityare encountered, the device can respond in different ways. If the devicedetects defect density or rate is above a first decision point, it mayslow down to allow more time for tissue flow and presumably betterstaple form. The detection of malformed staples (lack of detection ofgood form) also can be used to change the firing parameters in real timeto result in better staple formation with the remainder of the stapleline. If the device detects defect density or defect rate is above asecond decision point, it may display a warning to the surgeon prior tounclamping of where the defects are so that the surgeon can be preparedwith additional therapies to treat potential bleeding or stabilize thetissue as appropriate.

Before describing various aspects of a motorized stapling and cuttinginstrument (surgical instrument) as described in connection with FIGS.106-127, the present disclosure first turns to FIGS. 1-105 for a generaldescription of the mechanical and electrical platform upon which thepresent motorized surgical instrument may be implemented and providesthe background necessary to appreciate the underlying operation andfunctionality of the motorized surgical instrument. Accordingly, FIGS.1-14 provide an example of a general description of the underlyingmechanical platform upon which the present motorized stapling andcutting instrument may be implemented. FIGS. 15-21 describe examples ofthe general underlying microcontroller, motor drive, and electricalinterconnection platform upon which the present motorized surgicalinstrument may be implemented. FIGS. 22-34 describe example end effectorchannel frames and measuring forces applied to tissue located betweenthe anvil and the staple cartridge of the end effector. FIGS. 35-37described example circuits for controlling the functionality of thepresent motorized surgical instrument. FIGS. 38-95 describe examplesensors and feedback systems to utilize the sensors outputs to implementthe present motorized surgical instrument. FIGS. 97-97 describe examplepower assemblies for powering the present motorized surgical instrument.FIGS. 98-105 describe example control systems for controlling motorspeed and drivable members of the present surgical instrument includessensors and feedback elements therefor. Upon familiarization with theunderlying mechanical and electrical platform upon which the presentmotorized surgical instrument may be implemented, the reader is directedto the description in connection with FIGS. 106-127 for a description ofa motorized surgical stapling and cutting instrument configured todetect staple malformation as a trigger for making firing speedadjustments.

Accordingly, turning now to the figures, FIGS. 1-6 depict a motor-drivensurgical instrument 10 for cutting and fastening that may or may not bereused. In the illustrated examples, the surgical instrument 10 includesa housing 12 that comprises a handle assembly 14 that is configured tobe grasped, manipulated and actuated by the clinician. The housing 12 isconfigured for operable attachment to an interchangeable shaft assembly200 that has an end effector 300 operably coupled thereto that isconfigured to perform one or more surgical tasks or procedures. As thepresent Detailed Description proceeds, it will be understood that thevarious unique and novel arrangements of the various forms ofinterchangeable shaft assemblies disclosed herein also may beeffectively employed in connection with robotically-controlled surgicalsystems. Thus, the term “housing” also may encompass a housing orsimilar portion of a robotic system that houses or otherwise operablysupports at least one drive system that is configured to generate andapply at least one control motion which could be used to actuate theinterchangeable shaft assemblies disclosed herein and their respectiveequivalents. The term “frame” may refer to a portion of a handheldsurgical instrument. The term “frame” also may represent a portion of arobotically controlled surgical instrument and/or a portion of therobotic system that may be used to operably control a surgicalinstrument. For example, the interchangeable shaft assemblies disclosedherein may be employed with various robotic systems, instruments,components and methods disclosed in U.S. Pat. No. 9,072,535, entitledSURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENTARRANGEMENTS, which is incorporated by reference herein in its entirety.

The housing 12 depicted in FIGS. 1-2 is shown in connection with aninterchangeable shaft assembly 200 that includes an end effector 300that comprises a surgical cutting and fastening device that isconfigured to operably support a surgical staple cartridge 304 therein.The housing 12 may be configured for use in connection withinterchangeable shaft assemblies that include end effectors that areadapted to support different sizes and types of staple cartridges, havedifferent shaft lengths, sizes, and types, etc. In addition, the housing12 also may be effectively employed with a variety of otherinterchangeable shaft assemblies including those assemblies that areconfigured to apply other motions and forms of energy such as, forexample, radio frequency (RF) energy, ultrasonic energy and/or motion toend effector arrangements adapted for use in connection with varioussurgical applications and procedures. Furthermore, the end effectors,shaft assemblies, handles, surgical instruments, and/or surgicalinstrument systems can utilize any suitable fastener, or fasteners, tofasten tissue. For instance, a fastener cartridge comprising a pluralityof fasteners removably stored therein can be removably inserted intoand/or attached to the end effector of a shaft assembly.

FIG. 1 illustrates the surgical instrument 10 with an interchangeableshaft assembly 200 operably coupled thereto. FIG. 2 illustratesattachment of the interchangeable shaft assembly 200 to the housing 12or handle assembly 14. As shown in FIG. 4, the handle assembly 14 maycomprise a pair of interconnectable handle housing segments 16 and 18that may be interconnected by screws, snap features, adhesive, etc. Inthe illustrated arrangement, the handle housing segments 16, 18cooperate to form a pistol grip portion 19 that can be gripped andmanipulated by the clinician. As will be discussed in further detailbelow, the handle assembly 14 operably supports a plurality of drivesystems therein that are configured to generate and apply variouscontrol motions to corresponding portions of the interchangeable shaftassembly that is operably attached thereto.

Referring now to FIG. 4, the handle assembly 14 may further include aframe 20 that operably supports a plurality of drive systems. Forexample, the frame 20 can operably support a “first” or closure drivesystem, generally designated as 30, which may be employed to applyclosing and opening motions to the interchangeable shaft assembly 200that is operably attached or coupled thereto. In at least one form, theclosure drive system 30 may include an actuator in the form of a closuretrigger 32 that is pivotally supported by the frame 20. Morespecifically, as illustrated in FIG. 4, the closure trigger 32 ispivotally coupled to the handle assembly 14 by a pivot pin 33. Sucharrangement enables the closure trigger 32 to be manipulated by aclinician such that when the clinician grips the pistol grip portion 19of the handle assembly 14, the closure trigger 32 may be easily pivotedfrom a starting or “unactuated” position to an “actuated” position andmore particularly to a fully compressed or fully actuated position. Theclosure trigger 32 may be biased into the unactuated position by springor other biasing arrangement (not shown). In various forms, the closuredrive system 30 further includes a closure linkage assembly 34 that ispivotally coupled to the closure trigger 32. As shown in FIG. 4, theclosure linkage assembly 34 may include a first closure link 36 and asecond closure link 38 that are pivotally coupled to the closure trigger32 by a pin 35. The second closure link 38 also may be referred toherein as an “attachment member” and include a transverse attachment pin37.

Still referring to FIG. 4, it can be observed that the first closurelink 36 may have a an end or locking wall 39 thereon that is configuredto cooperate with a closure release assembly 60 that is pivotallycoupled to the frame 20. In at least one form, the closure releaseassembly 60 may comprise a closure release button assembly 62 that has adistally protruding locking pawl 64 formed thereon. The closure releasebutton assembly 62 may be pivoted in a counterclockwise direction by arelease spring (not shown). As the clinician depresses the closuretrigger 32 from its unactuated position towards the pistol grip portion19 of the handle assembly 14, the first closure link 36 pivots upward toa point wherein the locking pawl 64 drops into retaining engagement withthe locking wall 39 on the first closure link 36 thereby preventing theclosure trigger 32 from returning to the unactuated position. Thus, theclosure release assembly 60 serves to lock the closure trigger 32 in thefully actuated position. When the clinician desires to unlock theclosure trigger 32 to permit it to be biased to the unactuated position,the clinician simply pivots the closure release button assembly 62 suchthat the locking pawl 64 is moved out of engagement with the lockingwall 39 on the first closure link 36. When the locking pawl 64 has beenmoved out of engagement with the first closure link 36, the closuretrigger 32 may pivot back to the unactuated position. Other closuretrigger locking and release arrangements also may be employed.

Further to the above, FIGS. 10-11 illustrate the closure trigger 32 inits unactuated position which is associated with an open, or unclamped,configuration of the interchangeable shaft assembly 200 in which tissuecan be positioned between the jaws of the interchangeable shaft assembly200. FIG. 12 illustrates the closure trigger 32 in its actuated positionwhich is associated with a closed, or clamped, configuration of theinterchangeable shaft assembly 200 in which tissue is clamped betweenthe jaws of the interchangeable shaft assembly 200. Upon comparing FIGS.11 and 13, the reader will appreciate that, when the closure trigger 32is moved from its unactuated position (FIG. 11) to its actuated position(FIG. 13), the closure release button assembly 62 is pivoted between afirst position (FIG. 11) and a second position (FIG. 13). The rotationof the closure release button assembly 62 can be referred to as being anupward rotation; however, at least a portion of the closure releasebutton assembly 62 is being rotated toward the circuit board 100.Referring to FIG. 4, the closure release button assembly 62 can includean arm 61 extending therefrom and a magnetic element 63, such as apermanent magnet, for example, mounted to the arm 61. When the closurerelease button assembly 62 is rotated from its first position to itssecond position, the magnetic element 63 can move toward the circuitboard 100. The circuit board 100 can include at least one sensorconfigured to detect the movement of the magnetic element 63. In atleast one aspect, a magnetic field sensor 65, for example, can bemounted to the bottom surface of the circuit board 100. The magneticfield sensor 65 can be configured to detect changes in a magnetic fieldsurrounding the magnetic field sensor 65 caused by the movement of themagnetic element 63. The magnetic field sensor 65 can be in signalcommunication with a controller 1500, for example, which can determinewhether the closure release button assembly 62 is in its first position,which is associated with the unactuated position of the closure trigger32 and the open configuration of the end effector, its second position,which is associated with the actuated position of the closure trigger 32and the closed configuration of the end effector, and/or any positionbetween the first position and the second position.

As used throughout the present disclosure, a magnetic field sensor maybe a Hall effect sensor, search coil, fluxgate, optically pumped,nuclear precession, SQUID, Hall-effect, anisotropic magnetoresistance,giant magnetoresistance, magnetic tunnel junctions, giantmagnetoimpedance, magnetostrictive/piezoelectric composites,magnetodiode, magnetotransistor, fiber optic, magnetooptic, andmicroelectromechanical systems-based magnetic sensors, among others.

In at least one form, the handle assembly 14 and the frame 20 mayoperably support another drive system referred to herein as a firingdrive system 80 that is configured to apply firing motions tocorresponding portions of the interchangeable shaft assembly attachedthereto. The firing drive system may 80 also be referred to herein as a“second drive system”. The firing drive system 80 may employ an electricmotor 82, located in the pistol grip portion 19 of the handle assembly14. In various forms, the electric motor 82 may be a DC brushed drivingmotor having a maximum rotation of, approximately, 25,000 RPM, forexample. In other arrangements, the motor may include a brushless motor,a cordless motor, a synchronous motor, a stepper motor, or any othersuitable electric motor. The electric motor 82 may be powered by a powersource 90 that in one form may comprise a removable power pack 92. Asshown in FIG. 4, for example, the removable power pack 92 may comprise aproximal housing portion 94 that is configured for attachment to adistal housing portion 96. The proximal housing portion 94 and thedistal housing portion 96 are configured to operably support a pluralityof batteries 98 therein. Batteries 98 may each comprise, for example, aLithium Ion (“LI”) or other suitable battery. The distal housing portion96 is configured for removable operable attachment to a control circuitboard 100 which is also operably coupled to the electric motor 82. Anumber of batteries 98 may be connected in series may be used as thepower source for the surgical instrument 10. In addition, the powersource 90 may be replaceable and/or rechargeable.

As outlined above with respect to other various forms, the electricmotor 82 can include a rotatable shaft (not shown) that operablyinterfaces with a gear reducer assembly 84 that is mounted in meshingengagement with a with a set, or rack, of drive teeth 122 on alongitudinally movable drive member 120. In use, a voltage polarityprovided by the power source 90 can operate the electric motor 82 in aclockwise direction wherein the voltage polarity applied to the electricmotor by the battery can be reversed in order to operate the electricmotor 82 in a counter-clockwise direction. When the electric motor 82 isrotated in one direction, the longitudinally movable drive member 120will be axially driven in the distal direction “DD”. When the electricmotor 82 is driven in the opposite rotary direction, the longitudinallymovable drive member 120 will be axially driven in a proximal direction“PD”. The handle assembly 14 can include a switch which can beconfigured to reverse the polarity applied to the electric motor 82 bythe power source 90. As with the other forms described herein, thehandle assembly 14 can also include a sensor that is configured todetect the position of the longitudinally movable drive member 120and/or the direction in which the longitudinally movable drive member120 is being moved.

Actuation of the electric motor 82 can be controlled by a firing trigger130 that is pivotally supported on the handle assembly 14. The firingtrigger 130 may be pivoted between an unactuated position and anactuated position. The firing trigger 130 may be biased into theunactuated position by a spring 132 or other biasing arrangement suchthat when the clinician releases the firing trigger 130, it may bepivoted or otherwise returned to the unactuated position by the spring132 or biasing arrangement. In at least one form, the firing trigger 130can be positioned “outboard” of the closure trigger 32 as was discussedabove. In at least one form, a firing trigger safety button 134 may bepivotally mounted to the closure trigger 32 by pin 35. The firingtrigger safety button 134 may be positioned between the firing trigger130 and the closure trigger 32 and have a pivot arm 136 protrudingtherefrom. See FIG. 4. When the closure trigger 32 is in the unactuatedposition, the firing trigger safety button 134 is contained in thehandle assembly 14 where the clinician cannot readily access it and moveit between a safety position preventing actuation of the firing trigger130 and a firing position wherein the firing trigger 130 may be fired.As the clinician depresses the closure trigger 32, the firing triggersafety button 134 and the firing trigger 130 pivot down wherein they canthen be manipulated by the clinician.

As discussed above, the handle assembly 14 can include a closure trigger32 and a firing trigger 130. Referring to FIGS. 11-13, the firingtrigger 130 can be pivotably mounted to the closure trigger 32. Theclosure trigger 32 can include an arm 31 extending therefrom and thefiring trigger 130 can be pivotably mounted to the arm 31 about a pivotpin 33. When the closure trigger 32 is moved from its unactuatedposition (FIG. 11) to its actuated position (FIG. 13), the firingtrigger 130 can descend downwardly, as outlined above. After the firingtrigger safety button 134 has been moved to its firing position,referring primarily to FIG. 18A, the firing trigger 130 can be depressedto operate the motor of the surgical instrument firing system. Invarious instances, the handle assembly 14 can include a tracking system,such as system 800, for example, configured to determine the position ofthe closure trigger 32 and/or the position of the firing trigger 130.With primary reference to FIGS. 11 and 13, the tracking system 800 caninclude a magnetic element, such as magnet 802, for example, which ismounted to an arm 801 extending from the firing trigger 130. Thetracking system 800 can comprise one or more sensors, such as a firstmagnetic field sensor 803 and a second magnetic field sensor 804, forexample, which can be configured to track the position of the magnet802.

Upon comparing FIGS. 11 and 13, the reader will appreciate that, whenthe closure trigger 32 is moved from its unactuated position to itsactuated position, the magnet 802 can move between a first positionadjacent the first magnetic field sensor 803 and a second positionadjacent the second magnetic field sensor 804.

Upon comparing FIGS. 11 and 13, the reader will further appreciate that,when the firing trigger 130 is moved from an unfired position (FIG. 11)to a fired position (FIG. 13), the magnet 802 can move relative to thesecond magnetic field sensor 804. The first and second magnetic fieldsensors 803, 804 can track the movement of the magnet 802 and can be insignal communication with a controller on the circuit board 100. Withdata from the first magnetic field sensor 803 and/or the second magneticfield sensor 804, the controller can determine the position of themagnet 802 along a predefined path and, based on that position, thecontroller can determine whether the closure trigger 32 is in itsunactuated position, its actuated position, or a position therebetween.Similarly, with data from the first magnetic field sensor 803 and/or thesecond magnetic field sensor 804, the controller can determine theposition of the magnet 802 along a predefined path and, based on thatposition, the controller can determine whether the firing trigger 130 isin its unfired position, its fully fired position, or a positiontherebetween.

As indicated above, in at least one form, the longitudinally movabledrive member 120 has a rack of drive teeth 122 formed thereon formeshing engagement with a corresponding drive gear 86 of the gearreducer assembly 84. At least one form also includes amanually-actuatable bailout assembly 140 that is configured to enablethe clinician to manually retract the longitudinally movable drivemember 120 should the electric motor 82 become disabled. The bailoutassembly 140 may include a lever or handle assembly 14 that isconfigured to be manually pivoted into ratcheting engagement with teeth124 also provided in the longitudinally movable drive member 120. Thus,the clinician can manually retract the longitudinally movable drivemember 120 by using the handle assembly 14 to ratchet the longitudinallymovable drive member 120 in the proximal direction “PD”. U.S. Pat. No.8,608,045, entitled POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITHMANUALLY RETRACTABLE FIRING SYSTEM discloses bailout arrangements andother components, arrangements and systems that also may be employedwith the various instruments disclosed herein. U.S. Pat. No. 8,608,045,is herein incorporated by reference in its entirety.

Turning now to FIG. 1, the interchangeable shaft assembly 200 includesan end effector 300 that comprises an elongated channel 302 that isconfigured to operably support a surgical staple cartridge 304 therein.The end effector 300 may further include an anvil 306 that is pivotallysupported relative to the elongated channel 302. The interchangeableshaft assembly 200 may further include an articulation joint 270 and anarticulation lock 350 (FIG. 7) which can be configured to releasablyhold the end effector 300 in a desired position relative to a shaft axisSA-SA. Details regarding the construction and operation of the endeffector 300, the articulation joint 270 and the articulation lock 350are set forth in U.S. Patent Application Publication No. 2014/0263541,entitled ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATIONLOCK, which is herein incorporated by reference in its entirety. Asshown in FIG. 7, the interchangeable shaft assembly 200 can furtherinclude a proximal housing or nozzle 201 comprised of nozzle portions202, 203. The interchangeable shaft assembly 200 can further include aclosure tube 260 which can be utilized to close and/or open the anvil306 of the end effector 300. Primarily referring now to FIG. 7, theinterchangeable shaft assembly 200 can include a spine 210 which can beconfigured to fixably support a shaft frame 212 of the articulation lock350. See FIG. 7. The spine 210 can be configured to, one, slidablysupport a firing member 220 therein and, two, slidably support theclosure tube 260 which extends around the spine 210. The spine 210 canalso be configured to slidably support an articulation driver 230. Thearticulation driver 230 has a distal end 231 that is configured tooperably engage the articulation lock 350. The articulation lock 350interfaces with an articulation frame 352 that is adapted to operablyengage a drive pin (not shown) on the end effector frame (not shown). Asindicated above, further details regarding the operation of thearticulation lock 350 and the articulation frame may be found in U.S.Patent Application Publication No. 2014/0263541. In variouscircumstances, the spine 210 can comprise a proximal end 211 which isrotatably supported in a chassis 240. In one arrangement, for example,the proximal end 211 of the spine 210 has a thread 214 formed thereonfor threaded attachment to a spine bearing 216 configured to besupported within the chassis 240. Such an arrangement facilitatesrotatable attachment of the spine 210 to the chassis 240 such that thespine 210 may be selectively rotated about a shaft axis SA-SA relativeto the chassis 240.

The interchangeable shaft assembly 200 includes a closure shuttle 250that is slidably supported within the chassis 240 such that it may beaxially moved relative thereto. As shown in FIG. 3, the closure shuttle250 includes a pair of proximally-protruding hooks 252 that areconfigured for attachment to the transverse attachment pin 37 that isattached to the second closure link 38 as will be discussed in furtherdetail below. A proximal end 261 of the closure tube 260 is coupled tothe closure shuttle 250 for relative rotation thereto. For example, a Ushaped connector 263 is inserted into an annular slot 262 in theproximal end 261 of the closure tube 260 and is retained within verticalslots 253 in the closure shuttle 250. Such an arrangement serves toattach the closure tube 260 to the closure shuttle 250 for axial traveltherewith while enabling the closure tube 260 to rotate relative to theclosure shuttle 250 about the shaft axis SA-SA. A closure spring 268 isjournaled on the closure tube 260 and serves to bias the closure tube260 in the proximal direction “PD” which can serve to pivot the closuretrigger into the unactuated position when the shaft assembly is operablycoupled to the handle assembly 14.

In at least one form, the interchangeable shaft assembly 200 may furtherinclude an articulation joint 270. Other interchangeable shaftassemblies, however, may not be capable of articulation. According tovarious forms, the double pivot closure sleeve assembly 271 includes anend effector closure sleeve assembly 272 having upper and lower distallyprojecting tangs 273, 274. An end effector closure sleeve assembly 272includes a horseshoe aperture 275 and a tab 276 for engaging an openingtab on the anvil 306 in the various manners described in U.S. PatentApplication Publication No. 2014/0263541. As described in further detailtherein, the horseshoe aperture 275 and tab 276 engage a tab on theanvil when the anvil 306 is opened. An upper double pivot link 277includes upwardly projecting distal and proximal pivot pins that engagerespectively an upper distal pin hole in the upper proximally projectingtang 273 and an upper proximal pin hole in an upper distally projectingtang 264 on the closure tube 260. A lower double pivot link 278 includesupwardly projecting distal and proximal pivot pins that engagerespectively a lower distal pin hole in the lower proximally projectingtang 274 and a lower proximal pin hole in the lower distally projectingtang 265. See also FIG. 7.

In use, the closure tube 260 is translated distally (direction “DD”) toclose the anvil 306, for example, in response to the actuation of theclosure trigger 32. The anvil 306 is closed by distally translating theclosure tube 260 and thus the end effector closure sleeve assembly 272,causing it to strike a proximal surface on the anvil 306 in the mannerdescribed in the aforementioned reference U.S. Patent ApplicationPublication No. 2014/0263541. As was also described in detail in thatreference, the anvil 306 is opened by proximally translating the closuretube 260 and the end effector closure sleeve assembly 272, causing tab276 and the horseshoe aperture 275 to contact and push against the anviltab to lift the anvil 306. In the anvil-open position, the closure tube260 is moved to its proximal position.

As indicated above, the surgical instrument 10 may further include anarticulation lock 350 of the types and construction described in furtherdetail in U.S. Patent Application Publication No. 2014/0263541, whichcan be configured and operated to selectively lock the end effector 300in position. Such arrangement enables the end effector 300 to berotated, or articulated, relative to the closure tube 260 when thearticulation lock 350 is in its unlocked state. In such an unlockedstate, the end effector 300 can be positioned and pushed against softtissue and/or bone, for example, surrounding the surgical site withinthe patient in order to cause the end effector 300 to articulaterelative to the closure tube 260. The end effector 300 also may bearticulated relative to the closure tube 260 by an articulation driver230.

As was also indicated above, the interchangeable shaft assembly 200further includes a firing member 220 that is supported for axial travelwithin the spine 210. The firing member 220 includes an intermediatefiring shaft 222 that is configured for attachment to a distal cuttingportion or knife bar 280. The firing member 220 also may be referred toherein as a “second shaft” and/or a “second shaft assembly”. As shown inFIG. 7, the intermediate firing shaft 222 may include a longitudinalslot 223 in the distal end thereof which can be configured to receive atab 284 on the proximal end 282 of the knife bar 280. The longitudinalslot 223 and the proximal end 282 can be sized and configured to permitrelative movement therebetween and can comprise a slip joint 286. Theslip joint 286 can permit the intermediate firing shaft 222 of thefiring member 220 to be moved to articulate the end effector 300 withoutmoving, or at least substantially moving, the knife bar 280. Once theend effector 300 has been suitably oriented, the intermediate firingshaft 222 can be advanced distally until a proximal sidewall of thelongitudinal slot 223 comes into contact with the tab 284 in order toadvance the knife bar 280 and fire the staple cartridge positionedwithin the channel 302. As can be further seen in FIG. 7, the spine 210has an elongated opening or window 213 therein to facilitate assemblyand insertion of the intermediate firing shaft 222 into the spine 210.Once the intermediate firing shaft 222 has been inserted therein, a topframe segment 215 may be engaged with the shaft frame 212 to enclose theintermediate firing shaft 222 and knife bar 280 therein. Furtherdescription of the operation of the firing member 220 may be found inU.S. Patent Application Publication No. 2014/0263541.

Further to the above, the interchangeable shaft assembly 200 can includea clutch assembly 400 which can be configured to selectively andreleasably couple the articulation driver 230 to the firing member 220.In one form, the clutch assembly 400 includes a lock collar, or locksleeve 402, positioned around the firing member 220 wherein the locksleeve 402 can be rotated between an engaged position in which the locksleeve 402 couples the articulation driver 360 to the firing member 220and a disengaged position in which the articulation driver 360 is notoperably coupled to the firing member 220. When lock sleeve 402 is inits engaged position, distal movement of the firing member 220 can movethe articulation driver 360 distally and, correspondingly, proximalmovement of the firing member 220 can move the articulation driver 230proximally. When lock sleeve 402 is in its disengaged position, movementof the firing member 220 is not transmitted to the articulation driver230 and, as a result, the firing member 220 can move independently ofthe articulation driver 230. In various circumstances, the articulationdriver 230 can be held in position by the articulation lock 350 when thearticulation driver 230 is not being moved in the proximal or distaldirections by the firing member 220.

As shown in FIGS. 7-9, the interchangeable shaft assembly 200 furtherincludes a switch drum 500 that is rotatably received on the closuretube 260. The switch drum 500 comprises a hollow shaft segment 502 thathas a shaft boss 504 formed thereon for receive an outwardly protrudingactuation pin 410 therein. In various circumstances, the actuation pin410 extends through a slot 267 into a longitudinal slot 408 provided inthe lock sleeve 402 to facilitate axial movement of the lock sleeve 402when it is engaged with the articulation driver 230. A rotary torsionspring 420 is configured to engage the shaft boss 504 on the switch drum500 and a portion of the nozzle portion 203 as shown in FIG. 8 to applya biasing force to the switch drum 500. The switch drum 500 can furthercomprise at least partially circumferential openings 506 defined thereinwhich, referring to FIGS. 5 and 6, can be configured to receivecircumferential mounts 204, 205 extending from the nozzle portions 202,203 and permit relative rotation, but not translation, between theswitch drum 500 and the nozzle 201. As shown in those Figures, thecircumferential mounts 204, 205 also extend through openings 266 in theclosure tube 260 to be seated in recesses located in the spine 210.However, rotation of the nozzle 201 to a point where the circumferentialmounts 204, 205 reach the end of their respective partiallycircumferential openings 506 in the switch drum 500 will result inrotation of the switch drum 500 about the shaft axis SA-SA. Rotation ofthe switch drum 500 will ultimately result in the rotation of theactuation pin 410 and the lock sleeve 402 between its engaged anddisengaged positions. Thus, in essence, the nozzle 201 may be employedto operably engage and disengage the articulation drive system with thefiring drive system in the various manners described in further detailin U.S. Patent Application Publication No. 2014/0263541.

As also illustrated in FIGS. 7-9, the interchangeable shaft assembly 200can comprise a slip ring assembly 600 which can be configured to conductelectrical power to and/or from the end effector 300 and/or communicatesignals to and/or from the end effector 300, for example. The slip ringassembly 600 can comprise a proximal connector flange 604 mounted to achassis mounting flange 242 extending from the chassis 240 and a distalconnector flange 601 positioned within a slot defined in the nozzleportions 202, 203. The proximal connector flange 604 can comprise afirst face and the distal connector flange 601 can comprise a secondface which is positioned adjacent to and movable relative to the firstface. The distal connector flange 601 can rotate relative to theproximal connector flange 604 about the shaft axis SA-SA. The proximalconnector flange 604 can comprise a plurality of concentric, or at leastsubstantially concentric, conductors 602 defined in the first facethereof. A connector 607 can be mounted on the proximal side of thedistal connector flange 601 and may have a plurality of contacts (notshown) wherein each contact corresponds to and is in electrical contactwith one of the conductors 602. Such an arrangement permits relativerotation between the proximal connector flange 604 and the distalconnector flange 601 while maintaining electrical contact therebetween.The proximal connector flange 604 can include an electrical connector606 which can place the conductors 602 in signal communication with ashaft circuit board 610 mounted to the chassis 240, for example. In atleast one instance, a wiring harness comprising a plurality ofconductors can extend between the electrical connector 606 and the shaftcircuit board 610. The electrical connector 606 may extend proximallythrough a connector opening 243 defined in the chassis mounting flange242. U.S. Patent Application Publication No. 2014/0263551, entitledSTAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, is incorporated hereinby reference in its entirety. U.S. Patent Application Publication No.2014/0263552, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,is incorporated by reference in its entirety. Further details regardingslip ring assembly 600 may be found in U.S. Patent ApplicationPublication No. 2014/0263541.

As discussed above, the interchangeable shaft assembly 200 can include aproximal portion which is fixably mounted to the handle assembly 14 anda distal portion which is rotatable about a longitudinal axis. Therotatable distal shaft portion can be rotated relative to the proximalportion about the slip ring assembly 600, as discussed above. The distalconnector flange 601 of the slip ring assembly 600 can be positionedwithin the rotatable distal shaft portion. Moreover, further to theabove, the switch drum 500 can also be positioned within the rotatabledistal shaft portion. When the rotatable distal shaft portion isrotated, the distal connector flange 601 and the switch drum 500 can berotated synchronously with one another. In addition, the switch drum 500can be rotated between a first position and a second position relativeto the distal connector flange 601. When the switch drum 500 is in itsfirst position, the articulation drive system may be operably disengagedfrom the firing drive system and, thus, the operation of the firingdrive system may not articulate the end effector 300 of theinterchangeable shaft assembly 200. When the switch drum 500 is in itssecond position, the articulation drive system may be operably engagedwith the firing drive system and, thus, the operation of the firingdrive system may articulate the end effector 300 of the interchangeableshaft assembly 200. When the switch drum 500 is moved between its firstposition and its second position, the switch drum 500 is moved relativeto distal connector flange 601. In various instances, theinterchangeable shaft assembly 200 can comprise at least one sensorconfigured to detect the position of the switch drum 500. Turning now toFIG. 9, the distal connector flange 601 can comprise a magnetic fieldsensor 605, for example, and the switch drum 500 can comprise a magneticelement, such as permanent magnet 505, for example. The magnetic fieldsensor 605 can be configured to detect the position of the permanentmagnet 505. When the switch drum 500 is rotated between its firstposition and its second position, the permanent magnet 505 can moverelative to the magnetic field sensor 605. In various instances,magnetic field sensor 605 can detect changes in a magnetic field createdwhen the permanent magnet 505 is moved. The magnetic field sensor 605can be in signal communication with the shaft circuit board 610 and/orthe circuit board 100 located in the handle, for example. Based on thesignal from the magnetic field sensor 605, a controller on the shaftcircuit board 610 and/or the circuit board 100 located in the handle candetermine whether the articulation drive system is engaged with ordisengaged from the firing drive system.

Referring again to FIG. 3, the chassis 240 includes at least one, andpreferably two, tapered attachment portions 244 formed thereon that areadapted to be received within corresponding dovetail slots 702 formedwithin a distal attachment flange 700 of the frame 20. Each dovetailslot 702 may be tapered or, stated another way, be somewhat V-shaped toseatingly receive the tapered attachment portions 244 therein. As can befurther seen in FIG. 3, a shaft attachment lug 226 is formed on theproximal end of the intermediate firing shaft 222. As will be discussedin further detail below, when the interchangeable shaft assembly 200 iscoupled to the handle assembly 14, the shaft attachment lug 226 isreceived in a firing shaft attachment cradle 126 formed in the distalend 125 of the longitudinally movable drive member 120 as shown in FIGS.3 and 6, for example.

Various shaft assemblies employ a latch system 710 for removablycoupling the interchangeable shaft assembly 200 to the housing 12 andmore specifically to the frame 20. The proximally protruding lock lugs714 each have a pivot lock lugs 716 formed thereon that are adapted tobe received in corresponding holes 245 formed in the chassis 240. Sucharrangement facilitates pivotal attachment of the lock yoke 712 to thechassis 240. The lock yoke 712 may include two proximally protrudinglock lugs 714 that are configured for releasable engagement withcorresponding lock detents or grooves 704 in the distal attachmentflange 700 of the frame 20. See FIG. 3. In various forms, the lock yoke712 is biased in the proximal direction by spring or biasing member (notshown). Actuation of the lock yoke 712 may be accomplished by a latchbutton 722 that is slidably mounted on a latch actuator assembly 720that is mounted to the chassis 240. The latch button 722 may be biasedin a proximal direction relative to the lock yoke 712. As will bediscussed in further detail below, the lock yoke 712 may be moved to anunlocked position by biasing the latch button the in distal directionwhich also causes the lock yoke 712 to pivot out of retaining engagementwith the distal attachment flange 700 of the frame 20. When the lockyoke 712 is in “retaining engagement” with the distal attachment flange700 of the frame 20, the pivot lock lugs 716 are retainingly seatedwithin the corresponding lock detents or grooves 704 in the distalattachment flange 700.

When employing an interchangeable shaft assembly that includes an endeffector of the type described herein that is adapted to cut and fastentissue, as well as other types of end effectors, it may be desirable toprevent inadvertent detachment of the interchangeable shaft assemblyfrom the housing during actuation of the end effector. For example, inuse the clinician may actuate the closure trigger 32 to grasp andmanipulate the target tissue into a desired position. Once the targettissue is positioned within the end effector 300 in a desiredorientation, the clinician may then fully actuate the closure trigger 32to close the anvil 306 and clamp the target tissue in position forcutting and stapling. In that instance, the first drive system 30 hasbeen fully actuated. After the target tissue has been clamped in the endeffector 300, it may be desirable to prevent the inadvertent detachmentof the interchangeable shaft assembly 200 from the housing 12. One formof the latch system 710 is configured to prevent such inadvertentdetachment.

The lock yoke 712 includes at least one, and preferably two, lock hooks718 that are adapted to contact lock lugs 256 that are formed on theclosure shuttle 250. Referring to FIGS. 10 and 11, when the closureshuttle 250 is in an unactuated position (i.e., the first closure drivesystem 30 is unactuated and the anvil 306 is open), the lock yoke 712may be pivoted in a distal direction to unlock the interchangeable shaftassembly 200 from the housing 12. When in that position, the lock hooks718 do not contact the lock lugs 256 on the closure shuttle 250.However, when the closure shuttle 250 is moved to an actuated position(i.e., the first closure drive system 30 is actuated and the anvil 306is in the closed position), the lock yoke 712 is prevented from beingpivoted to an unlocked position. See FIGS. 12 and 13. Stated anotherway, if the clinician were to attempt to pivot the lock yoke 712 to anunlocked position or, for example, the lock yoke 712 was in advertentlybumped or contacted in a manner that might otherwise cause it to pivotdistally, the lock hooks 718 on the lock yoke 712 will contact the locklugs 256 on the closure shuttle 250 and prevent movement of the lockyoke 712 to an unlocked position.

Attachment of the interchangeable shaft assembly 200 to the handleassembly 14 will now be described with reference to FIG. 3. To commencethe coupling process, the clinician may position the chassis 240 of theinterchangeable shaft assembly 200 above or adjacent to the distalattachment flange 700 of the frame 20 such that the tapered attachmentportions 244 formed on the chassis 240 are aligned with the dovetailslots 702 in the frame 20. The clinician may then move theinterchangeable shaft assembly 200 along an installation axis IA that isperpendicular to the shaft axis SA-SA to seat the tapered attachmentportions 244 in “operable engagement” with the corresponding dovetailreceiving slots 702. In doing so, the shaft attachment lug 226 on theintermediate firing shaft 222 will also be seated in the firing shaftattachment cradle 126 in the longitudinally movable drive member 120 andthe portions of the transverse attachment pin 37 on the second closurelink 38 will be seated in the corresponding proximally-protruding hooks252 in the closure shuttle 250. As used herein, the term “operableengagement” in the context of two components means that the twocomponents are sufficiently engaged with each other so that uponapplication of an actuation motion thereto, the components may carry outtheir intended action, function and/or procedure.

As discussed above, at least five systems of the interchangeable shaftassembly 200 can be operably coupled with at least five correspondingsystems of the handle assembly 14. A first system can comprise a framesystem which couples and/or aligns the frame or spine of theinterchangeable shaft assembly 200 with the frame 20 of the handleassembly 14. Another system can comprise a closure drive system 30 whichcan operably connect the closure trigger 32 of the handle assembly 14and the closure tube 260 and the anvil 306 of the interchangeable shaftassembly 200. As outlined above, the closure shuttle 250 of theinterchangeable shaft assembly 200 can be engaged with the transverseattachment pin 37 on the second closure link 38. Another system cancomprise the firing drive system 80 which can operably connect thefiring trigger 130 of the handle assembly 14 with the intermediatefiring shaft 222 of the interchangeable shaft assembly 200.

As outlined above, the shaft attachment lug 226 can be operablyconnected with the firing shaft attachment cradle 126 of thelongitudinally movable drive member 120. Another system can comprise anelectrical system which can signal to a controller in the handleassembly 14, such as controller, for example, that a shaft assembly,such as the interchangeable shaft assembly 200, for example, has beenoperably engaged with the handle assembly 14 and/or, two, conduct powerand/or communication signals between the interchangeable shaft assembly200 and the handle assembly 14. For instance, the interchangeable shaftassembly 200 can include an electrical connector 1410 that is operablymounted to the shaft circuit board 610. The electrical connector 1410located on the shaft is configured for mating engagement with anelectrical connector 1400 on the circuit board 100 located in thehandle. Further details regaining the circuitry and control systems maybe found in U.S. Patent Application Publication No. 2014/0263541. Thefifth system may consist of the latching system for releasably lockingthe interchangeable shaft assembly 200 to the handle assembly 14.

Referring to FIG. 14, a non-limiting form of the end effector 300 isillustrated. As described above, the end effector 300 may include theanvil 306 and the surgical staple cartridge 304. In this non-limitingexample, the anvil 306 is coupled to an elongated channel 198. Forexample, apertures 199 can be defined in the elongated channel 198 whichcan receive pins 152 extending from the anvil 306 and allow the anvil306 to pivot from an open position to a closed position relative to theelongated channel 198 and surgical staple cartridge 304. In addition,FIG. 14 shows a firing bar 172, configured to longitudinally translateinto the end effector 300. The firing bar 172 may be constructed fromone solid section, or in various examples, may include a laminatematerial comprising, for example, a stack of steel plates. A distallyprojecting end of the firing bar 172 can be attached to an E-beam 178that can, among other things, assist in spacing the anvil 306 from asurgical staple cartridge 304 positioned in the elongated channel 198when the anvil 306 is in a closed position. The E-beam 178 can alsoinclude a sharpened cutting edge 182 which can be used to sever tissueas the E-beam 178 is advanced distally by the firing bar 172. Inoperation, the E-beam 178 can also actuate, or fire, the surgical staplecartridge 304. The surgical staple cartridge 304 can include a moldedcartridge body 194 that holds a plurality of staples 191 resting uponstaple drivers 192 within respective upwardly open staple cavities 195.A wedge sled 190 is driven distally by the E-beam 178, sliding upon acartridge tray 196 that holds together the various components of thesurgical staple cartridge 304. The wedge sled 190 upwardly cams thestaple drivers 192 to force out the staples 191 into deforming contactwith the anvil 306 while a cutting edge 182 of the E-beam 178 seversclamped tissue.

Further to the above, the E-beam 178 can include upper pins 180 whichengage the anvil 306 during firing. The E-beam 178 can further includemiddle pins 184 and a bottom foot 186 which can engage various portionsof the cartridge body 194, cartridge tray 196 and elongated channel 198.When a surgical staple cartridge 304 is positioned within the elongatedchannel 198, a slot 193 defined in the cartridge body 194 can be alignedwith a longitudinal slot 197 defined in the cartridge tray 196 and aslot 189 defined in the elongated channel 198. In use, the E-beam 178can slide through the aligned longitudinal slots 193, 197, and 189wherein, as indicated in FIG. 14, the bottom foot 186 of the E-beam 178can engage a groove running along the bottom surface of elongatedchannel 198 along the length of slot 189, the middle pins 184 can engagethe top surfaces of cartridge tray 196 along the length of longitudinalslot 197, and the upper pins 180 can engage the anvil 306. In suchcircumstances, the E-beam 178 can space, or limit the relative movementbetween, the anvil 306 and the surgical staple cartridge 304 as thefiring bar 172 is moved distally to fire the staples from the surgicalstaple cartridge 304 and/or incise the tissue captured between the anvil306 and the surgical staple cartridge 304. Thereafter, the firing bar172 and the E-beam 178 can be retracted proximally allowing the anvil306 to be opened to release the two stapled and severed tissue portions(not shown).

Having described a surgical instrument 10 (FIGS. 1-14) in general terms,the description now turns to a detailed description of variouselectrical/electronic components of the surgical instrument 10.Referring again to FIGS. 2 and 3, the handle assembly 14 can include anelectrical connector 1400 comprising a plurality of electrical contacts.Turning now to FIG. 15, the electrical connector 1400 can comprise afirst electrical contact 1401 a, a second electrical contact 1401 b, athird electrical contact 1401 c, a fourth electrical contact 1401 d, afifth electrical contact 1401 e, and a sixth electrical contact 1401 f,for example. While the illustrated example utilizes six contacts, otherexamples are envisioned which may utilize more than six contacts or lessthan six contacts.

As illustrated in FIG. 15, the first electrical contact 1401 a can be inelectrical communication with a transistor 1408, electrical contacts1401 b-1401 e can be in electrical communication with a controller 1500,and the sixth electrical contact 1401 f can be in electricalcommunication with a ground. In certain circumstances, one or more ofthe electrical contacts 1401 b-1401 e may be in electrical communicationwith one or more output channels of the controller 1500 and can beenergized, or have a voltage potential applied thereto, when the handle1042 is in a powered state. In some circumstances, one or more of theelectrical contacts 1401 b-1401 e may be in electrical communicationwith one or more input channels of the controller 1500 and, when thehandle assembly 14 is in a powered state, the controller 1500 can beconfigured to detect when a voltage potential is applied to suchelectrical contacts. When a shaft assembly, such as the interchangeableshaft assembly 200, for example, is assembled to the handle assembly 14,the electrical contacts 1401 a-1401 f may not communicate with eachother. When a shaft assembly is not assembled to the handle assembly 14,however, the electrical contacts 1401 a-1401 f of the electricalconnector 1400 may be exposed and, in some circumstances, one or more ofthe electrical contacts 1401 a-1401 f may be accidentally placed inelectrical communication with each other. Such circumstances can arisewhen one or more of the electrical contacts 1401 a-1401 f come intocontact with an electrically conductive material, for example. When thisoccurs, the controller 1500 can receive an erroneous input and/or theinterchangeable shaft assembly 200 can receive an erroneous output, forexample. To address this issue, in various circumstances, the handleassembly 14 may be unpowered when a shaft assembly, such as theinterchangeable shaft assembly 200, for example, is not attached to thehandle assembly 14.

In other circumstances, the handle 1042 can be powered when a shaftassembly, such as the interchangeable shaft assembly 200, for example,is not attached thereto. In such circumstances, the controller 1500 canbe configured to ignore inputs, or voltage potentials, applied to thecontacts in electrical communication with the controller 1500, i.e.,electrical contacts 1401 b-1401 e, for example, until a shaft assemblyis attached to the handle assembly 14. Even though the controller 1500may be supplied with power to operate other functionalities of thehandle assembly 14 in such circumstances, the handle assembly 14 may bein a powered-down state. In a way, the electrical connector 1400 may bein a powered-down state as voltage potentials applied to the electricalcontacts 1401 b-1401 e may not affect the operation of the handleassembly 14. The reader will appreciate that, even though electricalcontacts 1401 b-1401 e may be in a powered-down state, the electricalcontacts 1401 a and 1401 f, which are not in electrical communicationwith the controller 1500, may or may not be in a powered-down state. Forinstance, sixth electrical contact 1401 f may remain in electricalcommunication with a ground regardless of whether the handle assembly 14is in a powered-up or a powered-down state.

Furthermore, the transistor 1408, and/or any other suitable arrangementof transistors, such as transistor 1412, for example, and/or switchesmay be configured to control the supply of power from a power source1404, such as a battery, within the handle assembly 14, for example, tothe first electrical contact 1401 a regardless of whether the handleassembly 14 is in a powered-up or a powered-down state. In variouscircumstances, the interchangeable shaft assembly 200, for example, canbe configured to change the state of the transistor 1408 when theinterchangeable shaft assembly 200 is engaged with the handle assembly14. In certain circumstances, further to the below, a magnetic fieldsensor 1402 can be configured to switch the state of transistor 1412which, as a result, can switch the state of transistor 1408 andultimately supply power from power source 1404 to first electricalcontact 1401 a. In this way, both the power circuits and the signalcircuits to the electrical connector 1400 can be powered down when ashaft assembly is not installed to the handle assembly 14 and powered upwhen a shaft assembly is installed to the handle assembly 14.

In various circumstances, referring again to FIG. 15, the handleassembly 14 can include the magnetic field sensor 1402, for example,which can be configured to detect a detectable element, such as amagnetic element 1407 (FIG. 3), for example, on a shaft assembly, suchas the interchangeable shaft assembly 200, for example, when the shaftassembly is coupled to the handle assembly 14. The magnetic field sensor1402 can be powered by a power source 1406, such as a battery, forexample, which can, in effect, amplify the detection signal of themagnetic field sensor 1402 and communicate with an input channel of thecontroller 1500 via the circuit illustrated in FIG. 15. Once thecontroller 1500 has a received an input indicating that a shaft assemblyhas been at least partially coupled to the handle assembly 14, and that,as a result, the electrical contacts 1401 a-1401 f are no longerexposed, the controller 1500 can enter into its normal, or powered-up,operating state. In such an operating state, the controller 1500 willevaluate the signals transmitted to one or more of the electricalcontacts 1401 b-1401 e from the shaft assembly and/or transmit signalsto the shaft assembly through one or more of the electrical contacts1401 b-1401 e in normal use thereof. In various circumstances, theinterchangeable shaft assembly 200 may have to be fully seated beforethe magnetic field sensor 1402 can detect the magnetic element 1407.While a magnetic field sensor 1402 can be utilized to detect thepresence of the interchangeable shaft assembly 200, any suitable systemof sensors and/or switches can be utilized to detect whether a shaftassembly has been assembled to the handle assembly 14, for example. Inthis way, further to the above, both the power circuits and the signalcircuits to the electrical connector 1400 can be powered down when ashaft assembly is not installed to the handle assembly 14 and powered upwhen a shaft assembly is installed to the handle assembly 14.

In various examples, as may be used throughout the present disclosure,any suitable magnetic field sensor may be employed to detect whether ashaft assembly has been assembled to the handle assembly 14, forexample. For example, the technologies used for magnetic field sensinginclude Hall effect sensor, search coil, fluxgate, optically pumped,nuclear precession, SQUID (superconducting quantum interference device—avery sensitive magnetometer used to measure extremely subtle magneticfields, based on superconducting loops containing Josephson junctions),Hall-effect, anisotropic magnetoresistance, giant magnetoresistance,magnetic tunnel junctions, giant magnetoimpedance,magnetostrictive/piezoelectric composites, magnetodiode,magnetotransistor, fiber optic, magnetooptic, and microelectromechanicalsystems-based magnetic sensors, among others.

Referring to FIG. 15, the controller 1500 may generally comprise aprocessor (“microprocessor”) and one or more memory units operationallycoupled to the processor. By executing instruction code stored in thememory, the processor may control various components of the surgicalinstrument, such as the motor, various drive systems, and/or a userdisplay, for example. The controller 1500 may be implemented usingintegrated and/or discrete hardware elements, software elements, and/ora combination of both. Examples of integrated hardware elements mayinclude processors, microprocessors, controllers, controllers,integrated circuits, application specific integrated circuits (ASIC),programmable logic devices (PLD), digital signal processors (DSP), fieldprogrammable gate arrays (FPGA), logic gates, registers, semiconductordevices, chips, microchips, chip sets, controllers, system-on-chip(SoC), and/or system-in-package (SIP). Examples of discrete hardwareelements may include circuits and/or circuit elements such as logicgates, field effect transistors, bipolar transistors, resistors,capacitors, inductors, and/or relays. In certain instances, thecontroller 1500 may include a hybrid circuit comprising discrete andintegrated circuit elements or components on one or more substrates, forexample.

Referring to FIG. 15, the controller 1500 may be an LM4F230H5QR,available from Texas Instruments, for example. In certain instances, theTexas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising on-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QEI) analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available from the productdatasheet. Other controllers may be readily substituted for use with thepresent disclosure. Accordingly, the present disclosure should not belimited in this context.

As discussed above, the handle assembly 14 and/or the interchangeableshaft assembly 200 can include systems and configurations configured toprevent, or at least reduce the possibility of, the contacts of theelectrical connector 1400 located on the handle and/or the contacts ofthe electrical connector 1410 located on the shaft from becoming shortedout when the interchangeable shaft assembly 200 is not assembled, orcompletely assembled, to the handle assembly 14. Referring to FIG. 3,the electrical connector 1400 located on the handle can be at leastpartially recessed within a cavity 1409 defined in the frame 20. The sixelectrical contacts 1401 a-1401 f of the electrical connector 1400 canbe completely recessed within the cavity 1409. Such arrangements canreduce the possibility of an object accidentally contacting one or moreof the electrical contacts 1401 a-1401 f Similarly, the electricalconnector 1410 located on the shaft can be positioned within a recessdefined in the chassis 240 which can reduce the possibility of an objectaccidentally contacting one or more of the electrical contacts 1411a-1411 f of the electrical connector 1410 located on the shaft. Withregard to the particular example depicted in FIG. 3, the electricalcontacts 1411 a-1411 f located on the shaft can comprise male contacts.In at least one example, each of the electrical contacts 1411 a-1411 flocated in the shaft can comprise a flexible projection extendingtherefrom which can be configured to engage an electrical contact 1401a-1401 f located on the handle, for example. The electrical contacts1401 a-1401 f located on the handle can comprise female contacts. In atleast one example, each electrical contact 1401 a-1401 f located on thehandle can comprise a flat surface, for example, against which the maleelectrical contacts 1401 a-1401 f located on the shaft can wipe, orslide, against and maintain an electrically conductive interfacetherebetween. In various instances, the direction in which theinterchangeable shaft assembly 200 is assembled to the handle assembly14 can be parallel to, or at least substantially parallel to, theelectrical contacts 1401 a-1401 f located on the handle such that theelectrical contacts 1411 a-1411 f located on the shaft slide against theelectrical contacts 1401 a-1401 f located on the handle when theinterchangeable shaft assembly 200 is assembled to the handle assembly14. In various alternative examples, the electrical contacts 1401 a-1401f located in the handle can comprise male contacts and the electricalcontacts 1411 a-1411 f located on the shaft can comprise femalecontacts. In certain alternative examples, the electrical contacts 1401a-1401 f located on the handle and the electrical contacts 1411 a-1411 flocated on the shaft can comprise any suitable arrangement of contacts.

In various instances, the handle assembly 14 can comprise a connectorguard configured to at least partially cover the electrical connector1400 located on the handle and/or a connector guard configured to atleast partially cover the electrical connector 1410 located on theshaft. A connector guard can prevent, or at least reduce the possibilityof, an object accidentally touching the contacts of an electricalconnector when the shaft assembly is not assembled to, or only partiallyassembled to, the handle. A connector guard can be movable. Forinstance, the connector guard can be moved between a guarded position inwhich it at least partially guards a connector and an unguarded positionin which it does not guard, or at least guards less of, the connector.In at least one example, a connector guard can be displaced as the shaftassembly is being assembled to the handle. For instance, if the handlecomprises a handle connector guard, the shaft assembly can contact anddisplace the handle connector guard as the shaft assembly is beingassembled to the handle. Similarly, if the shaft assembly comprises ashaft connector guard, the handle can contact and displace the shaftconnector guard as the shaft assembly is being assembled to the handle.In various instances, a connector guard can comprise a door, forexample. In at least one instance, the door can comprise a beveledsurface which, when contacted by the handle or shaft, can facilitate thedisplacement of the door in a certain direction. In various instances,the connector guard can be translated and/or rotated, for example. Incertain instances, a connector guard can comprise at least one filmwhich covers the contacts of an electrical connector. When the shaftassembly is assembled to the handle, the film can become ruptured. In atleast one instance, the male contacts of a connector can penetrate thefilm before engaging the corresponding contacts positioned underneaththe film.

As described above, the surgical instrument can include a system whichcan selectively power-up, or activate, the contacts of an electricalconnector, such as the electrical connector 1400, for example. Invarious instances, the contacts can be transitioned between anunactivated condition and an activated condition. In certain instances,the contacts can be transitioned between a monitored condition, adeactivated condition, and an activated condition. For instance, thecontroller 1500, for example, can monitor the electrical contacts 1401a-1401 f when a shaft assembly has not been assembled to the handleassembly 14 to determine whether one or more of the electrical contacts1401 a-1401 f may have been shorted. The controller 1500 can beconfigured to apply a low voltage potential to each of the electricalcontacts 1401 a-1401 f and assess whether only a minimal resistance ispresent at each of the contacts. Such an operating state can comprisethe monitored condition. In the event that the resistance detected at acontact is high, or above a threshold resistance, the controller 1500can deactivate that contact, more than one contact, or, alternatively,all of the contacts. Such an operating state can comprise thedeactivated condition. If a shaft assembly is assembled to the handleassembly 14 and it is detected by the controller 1500, as discussedabove, the controller 1500 can increase the voltage potential to theelectrical contacts 1401 a-1401 f. Such an operating state can comprisethe activated condition.

The various shaft assemblies disclosed herein may employ sensors andvarious other components that require electrical communication with thecontroller in the housing. These shaft assemblies generally areconfigured to be able to rotate relative to the housing necessitating aconnection that facilitates such electrical communication between two ormore components that may rotate relative to each other. When employingend effectors of the types disclosed herein, the connector arrangementsmust be relatively robust in nature while also being somewhat compact tofit into the shaft assembly connector portion.

Turning now to FIGS. 16A and 16B, where one example of a segmentedcircuit 2000 comprising a plurality of circuit segments 2002 a-2002 g isillustrated. The segmented circuit 2000 comprising the plurality ofcircuit segments 2002 a-2002 g is configured to control a poweredsurgical instrument, such as, for example, the surgical instrument 10illustrated in FIGS. 1-13, without limitation. The plurality of circuitsegments 2002 a-2002 g is configured to control one or more operationsof the powered surgical instrument 10. A safety processor segment 2002 a(Segment 1) comprises a safety processor 2004. A primary processorsegment 2002 b (Segment 2) comprises a primary processor 2006. Thesafety processor 2004 and/or the primary processor 2006 are configuredto interact with one or more additional circuit segments 2002 c-2002 gto control operation of the powered surgical instrument 10. The primaryprocessor 2006 comprises a plurality of inputs coupled to, for example,one or more circuit segments 2002 c-2002 g, a battery 2008, and/or aplurality of switches 2058 a-2070. The segmented circuit 2000 may beimplemented by any suitable circuit, such as, for example, a printedcircuit board assembly (PCBA) within the powered surgical instrument 10.It should be understood that the term processor as used herein includesany microprocessor, processors, controller, controllers, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or at most a fewintegrated circuits. The processor is a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. It isan example of sequential digital logic, as it has internal memory.Processors operate on numbers and symbols represented in the binarynumeral system.

In one aspect, the primary processor 2006 may be any single core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one example, the safety processor 2004 may be asafety controller platform comprising two controller-based families suchas TMS570 and RM4x known under the trade name Hercules ARM Cortex R4,also by Texas Instruments. Nevertheless, other suitable substitutes forcontrollers and safety processor may be employed, without limitation. Inone example, the safety processor 2004 may be configured specificallyfor IEC 61508 and ISO 26262 safety critical applications, among others,to provide advanced integrated safety features while delivering scalableperformance, connectivity, and memory options. In certain instances, theprimary processor 2006 may be a single core or multicore controllerLM4F230H5QR as described in connection with FIGS. 14-17B.

In one aspect, the segmented circuit 2000 comprises an accelerationsegment 2002 c (Segment 3). The acceleration segment 2002 c comprises anaccelerometer 2022. The accelerometer 2022 is configured to detectmovement or acceleration of the powered surgical instrument 10. In someexamples, input from the accelerometer 2022 is used, for example, totransition to and from a sleep mode, identify an orientation of thepowered surgical instrument, and/or identify when the surgicalinstrument has been dropped. In some examples, the acceleration segment2002 c is coupled to the safety processor 2004 and/or the primaryprocessor 2006.

In one aspect, the segmented circuit 2000 comprises a display segment2002 d (Segment 4). The display segment 2002 d comprises a displayconnector 2024 coupled to the primary processor 2006. The displayconnector 2024 couples the primary processor 2006 to a display 2028through one or more integrated circuit drivers of the display 2026. Theintegrated circuit drivers of the display 2026 may be integrated withthe display 2028 and/or may be located separately from the display 2028.The display 2028 may comprise any suitable display, such as, forexample, an organic light-emitting diode (OLED) display, aliquid-crystal display (LCD), and/or any other suitable display. In someexamples, the display segment 2002 d is coupled to the safety processor2004.

In some aspects, the segmented circuit 2000 comprises a shaft segment2002 e (Segment 5). The shaft segment 2002 e comprises one or morecontrols for an interchangeable shaft assembly 200 (FIG. 1) coupled tothe surgical instrument 10 and/or one or more controls for an endeffector 300 coupled to the interchangeable shaft assembly 200 (FIG. 1).The shaft segment 2002 e comprises a shaft connector 2030 configured tocouple the primary processor 2006 to a shaft PCBA 2031. The shaft PCBA2031 comprises a first articulation switch 2036, a second articulationswitch 2032, and a shaft PCBA EEPROM 2034. In some examples, the shaftPCBA EEPROM 2034 comprises one or more parameters, routines, and/orprograms specific to the interchangeable shaft assembly 200 and/or theshaft PCBA 2031. The shaft PCBA 2031 may be coupled to theinterchangeable shaft assembly 200 and/or integral with the surgicalinstrument 10. In some examples, the shaft segment 2002 e comprises asecond shaft EEPROM 2038. The second shaft EEPROM 2038 comprises aplurality of algorithms, routines, parameters, and/or other datacorresponding to one or more shaft assemblies 200 and/or end effectors300 which may be interfaced with the powered surgical instrument 10.

In some aspects, the segmented circuit 2000 comprises a position encodersegment 2002 f (Segment 6). The position encoder segment 2002 fcomprises one or more magnetic angle rotary position encoders 2040a-2040 b. The one or more magnetic angle rotary position encoders 2040a-2040 b are configured to identify the rotational position of a motor2048, an interchangeable shaft assembly 200 (FIG. 1), and/or an endeffector 300 of the surgical instrument 10. In some examples, themagnetic angle rotary position encoders 2040 a-2040 b may be coupled tothe safety processor 2004 and/or the primary processor 2006.

In some aspects, the segmented circuit 2000 comprises a motor circuitsegment 2002 g (Segment 7). The motor circuit segment 2002 g comprises amotor 2048 configured to control one or more movements of the poweredsurgical instrument 10. The motor 2048 is coupled to the primaryprocessor 2006 by an H-Bridge driver 2042 and one or more H-bridgefield-effect transistors 2044 (FETs). The H-bridge FETs 2044 are coupledto the safety processor 2004. A motor current sensor 2046 is coupled inseries with the motor 2048 to measure the current draw of the motor2048. The motor current sensor 2046 is in signal communication with theprimary processor 2006 and/or the safety processor 2004. In someexamples, the motor 2048 is coupled to a motor electromagneticinterference (EMI) filter 2050.

In some aspects, the segmented circuit 2000 comprises a power segment2002 h (Segment 8). A battery 2008 is coupled to the safety processor2004, the primary processor 2006, and one or more of the additionalcircuit segments 2002 c-2002 g. The battery 2008 is coupled to thesegmented circuit 2000 by a battery connector 2010 and a current sensor2012. The current sensor 2012 is configured to measure the total currentdraw of the segmented circuit 2000. In some examples, one or morevoltage converters 2014 a, 2014 b, 2016 are configured to providepredetermined voltage values to one or more circuit segments 2002 a-2002g. For example, in some examples, the segmented circuit 2000 maycomprise 3.3V voltage converters 2014 a-2014 b and/or 5V voltageconverters 2016. A boost converter 2018 is configured to provide a boostvoltage up to a predetermined amount, such as, for example, up to 13V.The boost converter 2018 is configured to provide additional voltageand/or current during power intensive operations and prevent brownout orlow-power conditions.

In some aspects, the safety processor segment 2002 a comprises a motorpower switch 2020. The motor power switch 2020 is coupled between thepower segment 2002 h and the motor circuit segment 2002 g. The safetyprocessor segment 2002 a is configured to interrupt power to the motorcircuit segment 2002 g when an error or fault condition is detected bythe safety processor 2004 and/or the primary processor 2006 as discussedin more detail herein. Although the circuit segments 2002 a-2002 g areillustrated with all components of the circuit segments 2002 a-2002 hlocated in physical proximity, one skilled in the art will recognizethat a circuit segment 2002 a-2002 h may comprise components physicallyand/or electrically separate from other components of the same circuitsegment 2002 a-2002 g. In some examples, one or more components may beshared between two or more circuit segments 2002 a-2002 g.

In some aspects, a plurality of switches 2056-2070 are coupled to thesafety processor 2004 and/or the primary processor 2006. The pluralityof switches 2056-2070 may be configured to control one or moreoperations of the surgical instrument 10, control one or more operationsof the segmented circuit 2000, and/or indicate a status of the surgicalinstrument 10. For example, a bail-out door switch 2056 is configured toindicate the status of a bail-out door. A plurality of articulationswitches, such as, for example, a left side articulation left switch2058 a, a left side articulation right switch 2060 a, a left sidearticulation center switch 2062 a, a right side articulation left switch2058 b, a right side articulation right switch 2060 b, and a right sidearticulation center switch 2062 b are configured to control articulationof a shaft assembly 200 and/or an end effector 300. A left side reverseswitch 2064 a and a right side reverse switch 2064 b are coupled to theprimary processor 2006. In some examples, the left side switchescomprising the left side articulation left switch 2058 a, the left sidearticulation right switch 2060 a, the left side articulation centerswitch 2062 a, and the left side reverse switch 2064 a are coupled tothe primary processor 2006 by a left flex connector 2072 a. The rightside switches comprising the right side articulation left switch 2058 b,the right side articulation right switch 2060 b, the right sidearticulation center switch 2062 b, and the right side reverse switch2064 b are coupled to the primary processor 2006 by a right flexconnector 2072 b. In some examples, a firing switch 2066, a clamprelease switch 2068, and a shaft engaged switch 2070 are coupled to theprimary processor 2006.

In some aspects, the plurality of switches 2056-2070 may comprise, forexample, a plurality of handle controls mounted to a handle of thesurgical instrument 10, a plurality of indicator switches, and/or anycombination thereof. In various examples, the plurality of switches2056-2070 allow a surgeon to manipulate the surgical instrument, providefeedback to the segmented circuit 2000 regarding the position and/oroperation of the surgical instrument, and/or indicate unsafe operationof the surgical instrument 10. In some examples, additional or fewerswitches may be coupled to the segmented circuit 2000, one or more ofthe switches 2056-2070 may be combined into a single switch, and/orexpanded to multiple switches. For example, in one example, one or moreof the left side and/or right side articulation switches 2058 a-2064 bmay be combined into a single multi-position switch.

In one aspect, the safety processor 2004 is configured to implement awatchdog function, among other safety operations. The safety processor2004 and the primary processor 2006 of the segmented circuit 2000 are insignal communication. A processor alive heartbeat signal is provided atoutput 2097. The acceleration segment 2002 c comprises an accelerometer2022 configured to monitor movement of the surgical instrument 10. Invarious examples, the accelerometer 2022 may be a single, double, ortriple axis accelerometer. The accelerometer 2022 may be employed tomeasures proper acceleration that is not necessarily the coordinateacceleration (rate of change of velocity). Instead, the accelerometersees the acceleration associated with the phenomenon of weightexperienced by a test mass at rest in the frame of reference of theaccelerometer 2022. For example, the accelerometer 2022 at rest on thesurface of the earth will measure an acceleration g=9.8 m/s² (gravity)straight upwards, due to its weight. Another type of acceleration thataccelerometer 2022 can measure is g-force acceleration. In various otherexamples, the accelerometer 2022 may comprise a single, double, ortriple axis accelerometer. Further, the acceleration segment 2002 c maycomprise one or more inertial sensors to detect and measureacceleration, tilt, shock, vibration, rotation, and multipledegrees-of-freedom (DoF). A suitable inertial sensor may comprise anaccelerometer (single, double, or triple axis), a magnetometer tomeasure a magnetic field in space such as the earth's magnetic field,and/or a gyroscope to measure angular velocity.

In one aspect, the safety processor 2004 is configured to implement awatchdog function with respect to one or more circuit segments 2002c-2002 h, such as, for example, the motor circuit segment 2002 g. Inthis regards, the safety processor 2004 employs the watchdog function todetect and recover from malfunctions of the primary processor 2006.During normal operation, the safety processor 2004 monitors for hardwarefaults or program errors of the primary processor 2006 and to initiatecorrective action or actions. The corrective actions may include placingthe primary processor 2006 in a safe state and restoring normal systemoperation. In one example, the safety processor 2004 is coupled to atleast a first sensor. The first sensor measures a first property of thesurgical instrument 10 (FIGS. 1-4). In some examples, the safetyprocessor 2004 is configured to compare the measured property of thesurgical instrument 10 to a predetermined value. For example, in oneexample, a magnetic angle rotary position encoder 2040 a is coupled tothe safety processor 2004. The magnetic angle rotary position encoder2040 a provides motor speed and position information to the safetyprocessor 2004. The safety processor 2004 monitors the magnetic anglerotary position encoder 2040 a and compares the value to a maximum speedand/or position value and prevents operation of the motor 2048 above thepredetermined values. In some examples, the predetermined values arecalculated based on real-time speed and/or position of the motor 2048,calculated from values supplied by a second magnetic angle rotaryposition encoder 2040 b in communication with the primary processor2006, and/or provided to the safety processor 2004 from, for example, amemory module coupled to the safety processor 2004.

In some aspects, a second sensor is coupled to the primary processor2006. The second sensor is configured to measure the first physicalproperty. The safety processor 2004 and the primary processor 2006 areconfigured to provide a signal indicative of the value of the firstsensor and the second sensor respectively. When either the safetyprocessor 2004 or the primary processor 2006 indicates a value outsideof an acceptable range, the segmented circuit 2000 prevents operation ofat least one of the circuit segments 2002 c-2002 h, such as, forexample, the motor circuit segment 2002 g. For example, in the exampleillustrated in FIGS. 16A and 16B, the safety processor 2004 is coupledto a first magnetic angle rotary position encoder 2040 a and the primaryprocessor 2006 is coupled to a second magnetic angle rotary positionencoder 2040 b. The magnetic angle rotary position encoders 2040 a, 2040b may comprise any suitable motor position sensor, such as, for example,a magnetic angle rotary input comprising a sine and cosine output. Themagnetic angle rotary position encoders 2040 a, 2040 b providerespective signals to the safety processor 2004 and the primaryprocessor 2006 indicative of the position of the motor 2048.

The safety processor 2004 and the primary processor 2006 generate anactivation signal when the values of the first magnetic angle rotaryposition encoder 2040 a and the second magnetic angle rotary positionencoder 2040 b are within a predetermined range. When either the primaryprocessor 2006 or the safety processor 2004 to detect a value outside ofthe predetermined range, the activation signal is terminated andoperation of at least one of the circuit segments 2002 c-2002 h, suchas, for example, the motor circuit segment 2002 g, is interrupted and/orprevented. For example, in some examples, the activation signal from theprimary processor 2006 and the activation signal from the safetyprocessor 2004 are coupled to an AND gate. The AND gate is coupled to amotor power switch 2020. The AND gate maintains the motor power switch2020 in a closed, or on, position when the activation signal from boththe safety processor 2004 and the primary processor 2006 are high,indicating a value of the magnetic angle rotary position encoders 2040a, 2040 b within the predetermined range. When either of the magneticangle rotary position encoders 2040 a, 2040 b detect a value outside ofthe predetermined range, the activation signal from that magnetic anglerotary position encoder 2040 a, 2040 b is set low, and the output of theAND gate is set low, opening the motor power switch 2020. In someexamples, the value of the first magnetic angle rotary position encoder2040 a and the second magnetic angle rotary position encoder 2040 b iscompared, for example, by the safety processor 2004 and/or the primaryprocessor 2006. When the values of the first sensor and the secondsensor are different, the safety processor 2004 and/or the primaryprocessor 2006 may prevent operation of the motor circuit segment 2002g.

In some aspects, the safety processor 2004 receives a signal indicativeof the value of the second magnetic angle rotary position encoder 2040 band compares the second sensor value to the first sensor value. Forexample, in one aspect, the safety processor 2004 is coupled directly toa first magnetic angle rotary position encoder 2040 a. A second magneticangle rotary position encoder 2040 b is coupled to a primary processor2006, which provides the second magnetic angle rotary position encoder2040 b value to the safety processor 2004, and/or coupled directly tothe safety processor 2004. The safety processor 2004 compares the valueof the first magnetic angle rotary position encoder 2040 to the value ofthe second magnetic angle rotary position encoder 2040 b. When thesafety processor 2004 detects a mismatch between the first magneticangle rotary position encoder 2040 a and the second magnetic anglerotary position encoder 2040 b, the safety processor 2004 may interruptoperation of the motor circuit segment 2002 g, for example, by cuttingpower to the motor circuit segment 2002 g.

In some aspects, the safety processor 2004 and/or the primary processor2006 is coupled to a first magnetic angle rotary position encoder 2040 aconfigured to measure a first property of a surgical instrument and asecond magnetic angle rotary position encoder 2040 b configured tomeasure a second property of the surgical instrument. The first propertyand the second property comprise a predetermined relationship when thesurgical instrument is operating normally. The safety processor 2004monitors the first property and the second property. When a value of thefirst property and/or the second property inconsistent with thepredetermined relationship is detected, a fault occurs. When a faultoccurs, the safety processor 2004 takes at least one action, such as,for example, preventing operation of at least one of the circuitsegments, executing a predetermined operation, and/or resetting theprimary processor 2006. For example, the safety processor 2004 may openthe motor power switch 2020 to cut power to the motor circuit segment2002 g when a fault is detected.

In one aspect, the safety processor 2004 is configured to execute anindependent control algorithm. In operation, the safety processor 2004monitors the segmented circuit 2000 and is configured to control and/oroverride signals from other circuit components, such as, for example,the primary processor 2006, independently. The safety processor 2004 mayexecute a preprogrammed algorithm and/or may be updated or programmed onthe fly during operation based on one or more actions and/or positionsof the surgical instrument 10. For example, in one example, the safetyprocessor 2004 is reprogrammed with new parameters and/or safetyalgorithms each time a new shaft and/or end effector is coupled to thesurgical instrument 10. In some examples, one or more safety valuesstored by the safety processor 2004 are duplicated by the primaryprocessor 2006. Two-way error detection is performed to ensure valuesand/or parameters stored by either of the safety processor 2004 orprimary processor 2006 are correct.

In some aspects, the safety processor 2004 and the primary processor2006 implement a redundant safety check. The safety processor 2004 andthe primary processor 2006 provide periodic signals indicating normaloperation. For example, during operation, the safety processor 2004 mayindicate to the primary processor 2006 that the safety processor 2004 isexecuting code and operating normally. The primary processor 2006 may,likewise, indicate to the safety processor 2004 that the primaryprocessor 2006 is executing code and operating normally. In someexamples, communication between the safety processor 2004 and theprimary processor 2006 occurs at a predetermined interval. Thepredetermined interval may be constant or may be variable based on thecircuit state and/or operation of the surgical instrument 10.

FIGS. 17A and 17B illustrate another aspect of a segmented circuit 3000configured to control the powered surgical instrument 10, illustrated inFIGS. 1-14. As shown in FIGS. 14, 17B, the handle assembly 14 mayinclude an electric motor 3014 which can be controlled by a motor driver3015 and can be employed by the firing system of the surgical instrument10. In various forms, the electric motor 3014 may be a DC brusheddriving motor having a maximum rotation of, approximately, 25,000 RPM,for example. In other arrangements, the electric motor 3014 may includea brushless motor, a cordless motor, a synchronous motor, a steppermotor, or any other suitable electric motor. In certain circumstances,the motor driver 3015 may comprise an H-Bridge FETs 3019, as illustratedin FIGS. 17A and 17B, for example. The electric motor 3014 can bepowered by a power assembly 3006, which can be releasably mounted to thehandle assembly 14. The power assembly 3006 is configured to supplycontrol power to the surgical instrument 10. The power assembly 3006 maycomprise a battery which may include a number of battery cells connectedin series that can be used as the power source to power the surgicalinstrument 10. In such configuration, the power assembly 3006 may bereferred to as a battery pack. In certain circumstances, the batterycells of the power assembly 3006 may be replaceable and/or rechargeable.In at least one example, the battery cells can be Lithium-Ion batterieswhich can be separably couplable to the power assembly 3006.

Examples of drive systems and closure systems that are suitable for usewith the surgical instrument 10 are disclosed in U.S. Patent ApplicationPublication No. 2014/0263539, entitled CONTROL SYSTEMS FOR SURGICALINSTRUMENTS, now U.S. Pat. No. 9,629,629, which is incorporated hereinby reference herein in its entirety. For example, the electric motor3014 can include a rotatable shaft (not shown) that may operablyinterface with a gear reducer assembly that can be mounted in meshingengagement with a set, or rack, of drive teeth on alongitudinally-movable drive member. In use, a voltage polarity providedby the battery can operate the electric motor 3014 to drive thelongitudinally-movable drive member to effectuate the end effector 300.For example, the electric motor 3014 can be configured to drive thelongitudinally-movable drive member to advance a firing mechanism tofire staples into tissue captured by the end effector 300 from a staplecartridge assembled with the end effector 300 and/or advance a cuttingmember to cut tissue captured by the end effector 300, for example.

As illustrated in FIGS. 17A and 17B and as described below in greaterdetail, the power assembly 3006 may include a power managementcontroller which can be configured to modulate the power output of thepower assembly 3006 to deliver a first power output to power theelectric motor 3014 to advance the cutting member while theinterchangeable shaft assembly 200 is coupled to the handle assembly 14(FIG. 1) and to deliver a second power output to power the electricmotor 3014 to advance the cutting member while the interchangeable shaftassembly 200 is coupled to the handle assembly 14, for example. Suchmodulation can be beneficial in avoiding transmission of excessive powerto the electric motor 3014 beyond the requirements of an interchangeableshaft assembly that is coupled to the handle assembly 14.

In certain circumstances, the interface 3024 can facilitate transmissionof the one or more communication signals between the power managementcontroller 3016 and the shaft assembly controller 3022 by routing suchcommunication signals through a main controller 3017 residing in thehandle assembly 14 (FIG. 1), for example. In other circumstances, theinterface 3024 can facilitate a direct line of communication between thepower management controller 3016 and the shaft assembly controller 3022through the handle assembly 14 while the interchangeable shaft assembly200 (FIG. 1) and the power assembly 3006 are coupled to the handleassembly 14. In one instance, the main controller 3017 may be any singlecore or multicore processor such as those known under the trade name ARMCortex by Texas Instruments. In one instance, the surgical instrument 10(FIGS. 1-4) may comprise a power management controller 3016 such as, forexample, a safety controller platform comprising two controller-basedfamilies such as TMS570 and RM4x known under the trade name Hercules ARMCortex R4, also by Texas Instruments. Nevertheless, other suitablesubstitutes for controllers and safety processor may be employed,without limitation. In one instance, the safety processor 2004 (FIG. 16a) may be configured specifically for IEC 61508 and ISO 26262 safetycritical applications, among others, to provide advanced integratedsafety features while delivering scalable performance, connectivity, andmemory options.

In certain instances, the main controller 3017 may be a single core ormulticore controller LM4F230H5QR as described in connection with FIGS.15-17B.

FIG. 18 is a block diagram the surgical instrument of FIG. 1illustrating interfaces between the handle assembly 14 (FIG. 1) and thepower assembly and between the handle assembly 14 and theinterchangeable shaft assembly. As shown in FIG. 18, the power assembly3006 may include a power management circuit 3034 which may comprise thepower management controller 3016, a power modulator 3038, and a currentsense circuit 3036. The power management circuit 3034 can be configuredto modulate power output of the battery 3007 based on the powerrequirements of the interchangeable shaft assembly 200 (FIG. 1) whilethe interchangeable shaft assembly 200 and the power assembly 3006 arecoupled to the handle assembly 14. For example, the power managementcontroller 3016 can be programmed to control the power modulator 3038 ofthe power output of the power assembly 3006 and the current sensecircuit 3036 can be employed to monitor power output of the powerassembly 3006 to provide feedback to the power management controller3016 about the power output of the battery 3007 so that the powermanagement controller 3016 may adjust the power output of the powerassembly 3006 to maintain a desired output.

It is noteworthy that the power management controller 3016 and/or theshaft assembly controller 3022 each may comprise one or more processorsand/or memory units which may store a number of software modules.Although certain modules and/or blocks of the surgical instrument 10(FIG. 1) may be described by way of example, it can be appreciated thata greater or lesser number of modules and/or blocks may be used.Further, although various instances may be described in terms of modulesand/or blocks to facilitate description, such modules and/or blocks maybe implemented by one or more hardware components, e.g., processors,Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs),Application Specific Integrated Circuits (ASICs), circuits, registersand/or software components, e.g., programs, subroutines, logic and/orcombinations of hardware and software components.

In certain instances, the surgical instrument 10 (FIGS. 1-4) maycomprise an output device 3042 which may include one or more devices forproviding a sensory feedback to a user. Such devices may comprise, forexample, visual feedback devices (e.g., an LCD display screen, LEDindicators), audio feedback devices (e.g., a speaker, a buzzer) ortactile feedback devices (e.g., haptic actuators). In certaincircumstances, the output device 3042 may comprise a display 3043 whichmay be included in the handle assembly 14 (FIG. 1). The shaft assemblycontroller 3022 and/or the power management controller 3016 can providefeedback to a user of the surgical instrument 10 through the outputdevice 3042. The interface 3024 can be configured to connect the shaftassembly controller 3022 and/or the power management controller 3016 tothe output device 3042. The reader will appreciate that the outputdevice 3042 can instead be integrated with the power assembly 3006. Insuch circumstances, communication between the output device 3042 and theshaft assembly controller 3022 may be accomplished through the interface3024 while the interchangeable shaft assembly 200 is coupled to thehandle assembly 14.

Having described a surgical instrument 10 (FIGS. 1-4) and one or moresegmented circuit 2000, 3000 for controlling the operation thereof, thedisclosure now turns to various specific configurations of the surgicalinstrument 10 and a segmented circuit 2000 (or 3000).

In various aspects the present disclosure provides techniques for datastorage and usage. In one aspect, data storage and usage is based onmultiple levels of action thresholds. Such thresholds include upper andlower ultimate threshold limits, ultimate threshold that shuts downmotor or activates return is current, pressure, firing load, torque isexceeded, and alternatively, while running within the limits the deviceautomatically compensates for loading of the motor.

In one aspect, the surgical instrument 10 (described in connection withFIGS. 1-18) can be configured to monitor upper and lower ultimatethreshold limits to maintain minimum and maximum closure clamp loadswithin acceptable limits. If a minimum is not achieved the surgicalinstrument 10 cannot start or if it drops below minimum a user action isrequired. If the clamp load is at a suitable level but drops underminimum during firing, the surgical instrument 10 can adjust the speedof the motor or warn the user. If the minimum limit is breached duringoperation the unit could give a warning that the firing may not becompletely as anticipated. The surgical instrument 10 also can beconfigured to monitor when the battery voltage drops below the lowerultimate limit the remaining battery power is only direct able towardsreturning the device to the I-beam parked state. The opening force onthe anvil can be employed to sense jams in the end effector.Alternatively, the surgical instrument 10 can be configured to monitorwhen the motor current goes up or the related speed goes down, then themotor control increases pulse width or frequency modulation to keepspeed constant.

In another aspect, the surgical instrument 10 can (FIG. 1) be configuredto detect an ultimate threshold of current draw, pressure, firing load,torque such that when any of these thresholds are exceeded, the surgicalinstrument 10 shuts down the motor or causes the motor to return theknife to a pre-fired position. A secondary threshold, which is less thanthe ultimate threshold, may be employed to alter the motor controlprogram to accommodate changes in conditions by changing the motorcontrol parameters. A marginal threshold can be configured as a stepfunction or a ramp function based on a proportionate response to anothercounter or input. For example, in the case of sterilization, no changesbetween 0-200 sterilization cycles, slow motor 1% per use from 201-400sterilization cycles, and prevent use over 400 sterilization cycles. Thespeed of the motor also can be varied based on tissue gap and currentdraw.

There are many parameters that could influence the ideal function of apowered reusable stapler device. Most of these parameters have anultimate maximum and/or minimum threshold beyond which the device shouldnot be operated. Nevertheless, there are also marginal limits that mayinfluence the functional operation of the device. These multiple limits,from multiple parameters may provide an overlying and cumulative effecton the operations program of the device.

Accordingly, the present disclosure relates to surgical instruments and,in various circumstances, to surgical stapling and cutting instrumentsand staple cartridges therefor that are designed to staple and cuttissue.

Efficient performance of an electromechanical device depends on variousfactors. One is the operational envelope, i.e., range of parameters,conditions and events in which the device carries out its intendedfunctions. For example, for a device powered by a motor driven byelectrical current, there may be an operational region above a certainelectrical current threshold where the device runs more inefficientlythan desired. Put another way, there may be an upper “speed limit” abovewhich there is decreasing efficiency. Such an upper threshold may havevalue in preventing substantial inefficiencies or even devicedegradation.

There may be thresholds within an operational envelope, however, thatmay form regions exploitable to enhance efficiency within operationalstates. In other words, there may be regions where the device can adjustand perform better within a defined operational envelope (orsub-envelope). Such a region can be one between a marginal threshold andan ultimate threshold. In addition, these regions may comprise “sweetspots” or a predetermined optional range or point. These regions alsomay comprise a large range within which performance is judged to beadequate.

An ultimate threshold can be defined, above which or below which anaction or actions could be taken (or refrained from being taken) such asstopping the device. In addition, a marginal threshold or thresholds canbe defined, above which or below which an action or actions could betaken (or refrained from being taken). By way of non-limiting example, amarginal threshold can be set to define where the current draw of themotor exceeds 75% of an ultimate threshold. Exceeding the marginalthreshold can result, for example, in the device's beginning to slowmotor speed at an increasing rate as it continues to climb toward theultimate threshold.

Various mechanisms can be employed to carry out the adjustment(s) takenas a result of exceeding a threshold. For example, the adjustment canreflect a step function. It can also reflect a ramped function. Otherfunctions can be utilized.

In various aspects, to enhance performance by additional mechanisms, anoverlaying threshold can be defined. An overlaying threshold cancomprise one or more thresholds defined by multiple parameters. Anoverlaying threshold can result in one or more thresholds being an inputinto the generation of another threshold or thresholds. An overlayingthreshold can be predetermined or dynamically generated such as atruntime. The overlaying threshold may come into effect when you thethreshold is defined by multiple inputs. For example, as the number ofsterilization cycles exceeds 300 (the marginal threshold) but not 500(the ultimate threshold) the device runs the motor slower. Then as thecurrent draw exceeds its 75% marginal threshold it multiples the slowdown going even slower.

FIG. 19 illustrates a logic diagram of a system 4311 for evaluatingsharpness of a cutting edge 182 (FIG. 14) of a surgical instrument 10(FIGS. 1-4) according to various examples. In certain instances, thesystem 4311 can evaluate the sharpness of the cutting edge 182 bytesting the ability of the cutting edge 182 to be advanced through asharpness testing member 4302. For example, the system 4311 can beconfigured to observe the time period the cutting edge 182 takes tofully transect and/or completely pass through at least a predeterminedportion of a sharpness testing member 4302. If the observed time periodexceeds a predetermined threshold, the circuit 4310 may conclude thatthe sharpness of the cutting edge 182 has dropped below an acceptablelevel, for example.

In one aspect, the sharpness testing member 4302 can be employed to testthe sharpness of the cutting edge 182 (FIG. 14). In certain instances,the sharpness testing member 4302 can be attached to and/or integratedwith the cartridge body 194 (FIG. 14) of the surgical staple cartridge304 (FIGS. 1, 2, and 15), for example. In certain instances, thesharpness testing member 4302 can be disposed in the proximal portion ofthe surgical staple cartridge 304, for example. In certain instances,the sharpness testing member 4302 can be disposed onto a cartridge deckor cartridge body 194 of the surgical staple cartridge 304, for example.

In certain instances, a load cell 4335 can be configured to monitor theforce (Fx) applied to the cutting edge 182 (FIG. 14) while the cuttingedge 182 is engaged and/or in contact with the sharpness testing member4302, for example. The reader will appreciate that the force (Fx)applied by the sharpness testing member 4302 to the cutting edge 182while the cutting edge 182 is engaged and/or in contact with thesharpness testing member 4302 may depend, at least in part, on thesharpness of the cutting edge 182. In certain instances, a decrease inthe sharpness of the cutting edge 182 can result in an increase in theforce (Fx) required for the cutting edge 182 to cut or pass through thesharpness testing member 4302. The load cell 4335 of the sharpnesstesting member 4302 may be employed to measure the force (Fx) applied tothe cutting edge 182 while the cutting edge 182 travels a predefineddistance (D) through the sharpness testing member 4302 may be employedto determine the sharpness of the cutting edge 182.

In certain instances, the system 4311 may include a controller 4313(“microcontroller”) which may include a processor 4315(“microprocessor”) and one or more computer readable mediums or memory4317 units (“memory”). In certain instances, the memory 4317 may storevarious program instructions, which when executed may cause theprocessor 4315 to perform a plurality of functions and/or calculationsdescribed herein. In certain instances, the memory 4317 may be coupledto the processor 4315, for example. A power source 4319 can beconfigured to supply power to the controller 4313, for example. Incertain instances, the power source 4319 may comprise a battery (or“battery pack” or “power pack”), such as a Li ion battery, for example.In certain instances, the battery pack may be configured to bereleasably mounted to the handle assembly 14. A number of battery cellsconnected in series may be used as the power source 4319. In certaininstances, the power source 4319 may be replaceable and/or rechargeable,for example.

In certain instances, the controller 4313 can be operably coupled to thefeedback system and/or the lockout mechanism 4123, for example.

The system 4311 may comprise one or more position sensors. Exampleposition sensors and positioning systems suitable for use with thepresent disclosure are described in U.S. Patent Application PublicationNo. 2014/0263538, entitled SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONINGSYSTEM FOR SURGICAL INSTRUMENTS, now U.S. Pat. No. 9,808,244, which isherein incorporated by reference in its entirety. In certain instances,the system 4311 may include a first position sensor 4321 and a secondposition sensor 4323. In certain instances, the first position sensor4321 can be employed to detect a first position of the cutting edge 182(FIG. 14) at a proximal end of a sharpness testing member 4302, forexample; and the second position sensor 4323 can be employed to detect asecond position of the cutting edge 182 at a distal end of a sharpnesstesting member 4302, for example.

In certain instances, the first and second position sensors 4321, 4323can be employed to provide first and second position signals,respectively, to the controller 4313. It will be appreciated that theposition signals may be analog signals or digital values based on theinterface between the controller 4313 and the first and second positionsensors 4321, 4323. In one example, the interface between the controller4313 and the first and second position sensors 4321, 4323 can be astandard serial peripheral interface (SPI), and the position signals canbe digital values representing the first and second positions of thecutting edge 182, as described above.

Further to the above, the processor 4315 may determine the time periodbetween receiving the first position signal and receiving the secondposition signal. The determined time period may correspond to the timeit takes the cutting edge 182 (FIG. 14) to advance through a sharpnesstesting member 4302 from the first position at a proximal end of thesharpness testing member 4302, for example, to a second position at adistal end of the sharpness testing member 4302, for example. In atleast one example, the controller 4313 may include a time element whichcan be activated by the processor 4315 upon receipt of the firstposition signal, and deactivated upon receipt of the second positionsignal. The time period between the activation and deactivation of thetime element may correspond to the time it takes the cutting edge 182 toadvance from the first position to the second position, for example. Thetime element may comprise a real time clock, a processor configured toimplement a time function, or any other suitable timing circuit.

In various instances, the controller 4313 can compare the time period ittakes the cutting edge 182 (FIG. 14) to advance from the first positionto the second position to a predefined threshold value to assess whetherthe sharpness of the cutting edge 182 has dropped below an acceptablelevel, for example. In certain instances, the controller 4313 mayconclude that the sharpness of the cutting edge 182 has dropped below anacceptable level if the measured time period exceeds the predefinedthreshold value by 1%, 5%, 10%, 25%, 50%, 100% and/or more than 100%,for example.

FIG. 20 illustrates a logic diagram of a system 4340 for determining theforces applied against a cutting edge of a surgical instrument 10 (FIGS.1-4) by a sharpness testing member 4302 at various sharpness levelsaccording to various aspects. Referring to FIG. 20, in variousinstances, an electric motor 4331 can drive the firing bar 172 (FIG. 20)to advance the cutting edge 182 (FIG. 14) during a firing stroke and/orto retract the cutting edge 182 during a return stroke, for example. Amotor driver 4333 can control the electric motor 4331; and a controllersuch as, for example, the controller 4313 can be in signal communicationwith the motor driver 4333. As the electric motor 4331 advances thecutting edge 182, the controller 4313 can determine the current drawn bythe electric motor 4331, for example. In such instances, the forcerequired to advance the cutting edge 182 can correspond to the currentdrawn by the electric motor 4331, for example. Referring still to FIG.20, the controller 4313 of the surgical instrument 10 can determine ifthe current drawn by the electric motor 4331 increases duringadvancement of the cutting edge 182 and, if so, can calculate thepercentage increase of the current.

In certain instances, the current drawn by the electric motor 4331 mayincrease significantly while the cutting edge 182 (FIG. 14) is incontact with the sharpness testing member 4302 due to the resistance ofthe sharpness testing member 4302 to the cutting edge 182. For example,the current drawn by the electric motor 4331 may increase significantlyas the cutting edge 182 engages, passes and/or cuts through thesharpness testing member 4302. The reader will appreciate that theresistance of the sharpness testing member 4302 to the cutting edge 182depends, in part, on the sharpness of the cutting edge 182; and as thesharpness of the cutting edge 182 decreases from repetitive use, theresistance of the sharpness testing member 4302 to the cutting edge 182will increase. Accordingly, the value of the percentage increase of thecurrent drawn by the electric motor 4331 while the cutting edge is incontact with the sharpness testing member 4302 can increase as thesharpness of the cutting edge 182 decreases from repetitive use, forexample.

In certain instances, the determined value of the percentage increase ofthe current drawn by the electric motor 4331 can be the maximum detectedpercentage increase of the current drawn by the electric motor 4331. Invarious instances, the controller 4313 can compare the determined valueof the percentage increase of the current drawn by the electric motor4331 to a predefined threshold value of the percentage increase of thecurrent drawn by the electric motor 4331. If the determined valueexceeds the predefined threshold value, the controller 4313 may concludethat the sharpness of the cutting edge 182 has dropped below anacceptable level, for example.

In certain instances, as illustrated in FIG. 20, the processor 4315 canbe in communication with the feedback system and/or the lockoutmechanism for example. In certain instances, the processor 4315 canemploy the feedback system to alert a user if the determined value ofthe percentage increase of the current drawn by the electric motor 4331exceeds the predefined threshold value, for example. In certaininstances, the processor 4315 may employ the lockout mechanism toprevent advancement of the cutting edge 182 (FIG. 14) if the determinedvalue of the percentage increase of the current drawn by the electricmotor 4331 exceeds the predefined threshold value, for example. Incertain instances, the system 4311 may include first and second positionsensors 4321, 4323. The surgical instrument 10 (FIGS. 1-4) may include aload cell 4335.

In various instances, the controller 4313 can utilize an algorithm todetermine the change in current drawn by the electric motor 4331. Forexample, a current sensor can detect the current drawn by the electricmotor 4331 during the firing stroke. The current sensor can continuallydetect the current drawn by the electric motor and/or can intermittentlydetect the current draw by the electric motor. In various instances, thealgorithm can compare the most recent current reading to the immediatelyproceeding current reading, for example. Additionally or alternatively,the algorithm can compare a sample reading within a time period X to aprevious current reading. For example, the algorithm can compare thesample reading to a previous sample reading within a previous timeperiod X, such as the immediately proceeding time period X, for example.In other instances, the algorithm can calculate the trending average ofcurrent drawn by the motor. The algorithm can calculate the averagecurrent draw during a time period X that includes the most recentcurrent reading, for example, and can compare that average current drawto the average current draw during an immediately proceeding time periodtime X, for example.

In certain instances, the load cell 4335 (FIGS. 19, 20) can beconfigured to monitor the force (Fx) applied to the cutting edge 182(FIG. 14) while the cutting edge 182 is engaged and/or in contact withthe sharpness testing member 4302 (FIGS. 19, 20), for example. Thereader will appreciate that the force (Fx) applied by the sharpnesstesting member 4302 to the cutting edge 182 while the cutting edge 182is engaged and/or in contact with the sharpness testing member 4302 maydepend, at least in part, on the sharpness of the cutting edge 182. Incertain instances, a decrease in the sharpness of the cutting edge 182can result in an increase in the force (Fx) required for the cuttingedge 182 to cut or pass through the sharpness testing member 4302. Incertain instances, the controller 4313 (FIGS. 19, 20) may compare amaximum value of the monitored force (Fx) applied to the cutting edge182 (FIG. 14) to one or more predefined threshold values.

In certain instances, the cutting edge 182 (FIG. 14) may be sufficientlysharp for transecting a captured tissue comprising a first thickness butmay not be sufficiently sharp for transecting a captured tissuecomprising a second thickness greater than the first thickness, forexample. In certain instances, a sharpness level of the cutting edge182, as defined by the force required for the cutting edge 182 totransect a captured tissue, may be adequate for transecting the capturedtissue if the captured tissue comprises a tissue thickness that is in aparticular range of tissue thicknesses, for example. In certaininstances, the memory 4317 (FIGS. 19, 20) can store one or morepredefined ranges of tissue thicknesses of tissue captured by the endeffector 300; and predefined threshold forces associated with thepredefined ranges of tissue thicknesses. In certain instances, eachpredefined threshold force may represent a minimum sharpness level ofthe cutting edge 182 that is suitable for transecting a captured tissuecomprising a tissue thickness (Tx) encompassed by the range of tissuethicknesses that is associated with the predefined threshold force. Incertain instances, when the force (Fx) required for the cutting edge 182to transect the captured tissue, comprising the tissue thickness (Tx),exceeds the predefined threshold force associated with the predefinedrange of tissue thicknesses that encompasses the tissue thickness (Tx),the cutting edge 182 may not be sufficiently sharp to transect thecaptured tissue, for example.

In various aspects, the present disclosure provides techniques fordetermining tissue compression and additional techniques to control theoperation of the surgical instrument 10 (described in connection withFIGS. 1-18) in response to the tissue compression. In one example, thecartridges may be configured to define variable compression algorithmwhich drives the surgical instrument 10 to close differently based onintended tissue type and thickness. In another example, the surgicalinstrument 10 learns from surgeon use and original tissue compressionprofile to adapt closure based on load experienced during firing. Whenthe surgical instrument 10 experiences tissue compression loads that aredramatically different that those experienced for this cartridge typethe instrument highlights this to the user.

Active adjustment of a motor control algorithm over time as theinstrument become acclimated to the hospital's usage can improve thelife expectancy of a rechargeable battery as well as adjust totissue/procedure requirements of minimizing tissue flow, thus improvingstaple formation in the tissue seal.

Accordingly, the present disclosure relates to surgical instruments and,in various circumstances, to surgical stapling and cutting instrumentsand staple cartridges therefor that are designed to staple and cuttissue. For example, in various aspects the present disclosure providesan endosurgical instrument configured to sense the cartridge type ortissue gap to enable the handle to adjust the closure and firingalgorithms to adjust for intended tissue properties. This adaptivealgorithm adjustment can “learn” from the user's operations allowing thedevice to react and benefit two different systems. The first benefitprovided by the disclosed adaptive algorithm includes tissue flow andstaple formation. As the device learns the users' basic habits and steptimings, the device can adjust the closure speed and firing speed toprovide a more consistent and reliable output. The second benefitprovided by the disclosed adaptive algorithm is related to the batterypack. As the device learns how many firings and what conditions theinstrument was used, the device can adjust motor current needs/speed ina predefined manner to prolong battery life. There is a substantiallysmall likelihood that a device used in a hospital that performspredominantly bariatric procedures would be operated in a manner similarto a device used in a hospital that performs mostly colorectal orthoracic procedures. Thus, when the device is used to performsubstantially similar procedure, over time, the device is configured tolearn and adjust its operational algorithm to maintain within the“ideal” discharge and tissue flow envelopes.

Safe and effective surgery requires due knowledge of, and respect for,the tissue involved. Clinicians are mindful that adjustments made duringsurgery may be beneficial. These adjustments include mechanisms todetect and promote desirable staple formation.

Endosurgical instruments can generate, monitor and process a substantialamount of data during their use in connection with a surgical procedure.Such data can be obtained from the surgical instrument itself, includingbattery usage. Additionally, data can be obtained from the properties ofthe tissue with which the surgical instrument interacts, includingproperties such as tissue compression. Further, data can be obtainedfrom the clinician's interaction with the surgical instrument itself.The repository of data so obtained can be processed and, where desired,the surgical instrument can be designed to adapt to circumstances so asto promote a safe and effective outcome to the current surgicalprocedure, as well as lay the foundation for more generalized productiveuse by multiple clinicians. Such adaptive adjustments—both during asurgical procedure, and wherein the instrument “learns” based on usagepatterns drawn from multiple surgical procedures—can provide numerousmechanisms to enhance the overall patient-care environment.

FIG. 21 illustrates one aspect of a process for adapting operations of asurgical instrument. As depicted in FIG. 21, a module can be attached5160 or otherwise loaded to the surgical instrument 10 (FIGS. 1-4). Themodule can contain a program that is selected or uploaded 5162. Controlscan be activated 5164 such that they can be ready to operate thesurgical instrument 10. During or after usage of the surgical instrument10, control measures can be included to adapt 5166 a program. Forexample, this can include adjusting the data rate within the surgicalinstrument 10 or with respect to remote operation of the surgicalinstrument 10. This can include adjusting speed, such as speed by whichanvil 306 (FIG. 1) and surgical staple cartridge 304 (FIG. 1) engage ina closure motion. This can also include a pulse from an emitter andsensor or to apply a pulse of electrical current to tissue, and thetiming of such pulse. This can include adjusting a program to adapt toacceleration, such as acceleration of the surgical instrument 10 ifdropped, or transition from a sleep mode. A program can be adapted tohandle an actual and/or expected load based on clamping force.

The surgical instrument 10 (FIGS. 1-4) can be employed to complete anaction 5168, for example to carry out a stapling procedure. Data can berecorded 5170 in appropriate memory locations of the surgical instrument10. Sensor behavior 5172 can be assessed, such as to what extent asensor accurately measured and/or measures a parameter. Anticipated datacan be assessed 5174, including but not limited to tissue properties,wait period and firing speed. Foregoing mechanisms disclosed herein canprovide an input to adapt 5166 a program further. In addition, a tissueidentification 5178 can be performed, based on historical, actual orexpected tissue properties, and this can provide an input to furtheradapt 5166 a program. In addition, tissue identification 5178 propertiescan be updated. Moreover, measured sensor input 5176 during a procedurecan be used as an additional input to further adapt 5166 a program; suchsensor measurements can include those of the gap between anvil 306 andsurgical staple cartridge 304, obtaining a derivative measurementincluding a derivative of a function, current, or torque.

The end-effector 6006 may be used to compress, cut, or staple tissue.Referring now to FIG. 23A, an end-effector 6030 may be positioned by aphysician to surround tissue 6032 prior to compression, cutting, orstapling. As shown in FIG. 23A, no compression may be applied to thetissue while preparing to use the end-effector. Referring now to FIG.23B, by engaging the handle (e.g., handle 6002) of the endocutter, thephysician may use the end-effector 6030 to compress the tissue 6032. Inone aspect, the tissue 6032 may be compressed to its maximum threshold,as shown in FIG. 23B.

Referring to FIG. 23A, various forces may be applied to the tissue 6032by the end-effector 6030. For example, vertical forces F1 and F2 may beapplied by the anvil 6034 and the channel frame 6036 of the end-effector6030 as tissue 6032 is compressed between the two. Referring now to FIG.23B, various diagonal and/or lateral forces also may be applied to thetissue 6032 when compressed by the end-effector 6030. For example, forceF3 may be applied. For the purposes of operating a medical device suchas endocutter 6000, it may be desirable to sense or calculate thevarious forms of compression being applied to the tissue by theend-effector. For example, knowledge of vertical or lateral compressionmay allow the end-effector to more precisely or accurately apply astaple operation or may inform the operator of the endocutter such thatthe endocutter can be used more properly or safely.

The compression through tissue 6032 may be determined from an impedanceof tissue 6032. At various levels of compression, the impedance Z oftissue 6032 may increase or decrease. By applying a voltage V and acurrent I to the tissue 6032, the impedance Z of the tissue 6032 may bedetermined at various levels of compression. For example, impedance Zmay be calculated by dividing the applied voltage V by the current I.

Referring now to FIG. 24, in one aspect, an RF electrode 6038 may bepositioned on the end-effector 6030 (e.g., on a staple cartridge, knife,or channel frame of the end-effector 6030). Further, an electricalcontact 6040 may be positioned on the anvil 6034 of the end-effector6030. In one aspect, the electrical contact may be positioned on thechannel frame of the end-effector. As the tissue 6032 is compressedbetween the anvil 6034 and, for example, the channel frame 6036 of theend-effector 6030, an impedance Z of the tissue 6032 changes. Thevertical tissue compression 6042 caused by the end-effector 6030 may bemeasured as a function of the impedance Z of the tissue 6032.

Referring now to FIG. 25, in one aspect, an electrical contact 6044 maybe positioned on an opposite end of the anvil 6034 of the end-effector6030 as the RF electrode 6038 is positioned. As the tissue 6032 iscompressed between the anvil 6034 and, for example, the channel frame6036 of the end-effector 6030, an impedance Z of the tissue 6032changes. The lateral tissue compression 6046 caused by the end-effector6030 may be measured as a function of the impedance Z of the tissue6032.

Referring now to FIG. 26, in one aspect, electrical contact 6050 may bepositioned on the anvil 6034 and electrical contact 6052 may bepositioned on an opposite end of the end-effector 6030 at channel frame6036. RF electrode 6048 may be positioned laterally to the central tothe end-effector 6030. As the tissue 6032 is compressed between theanvil 6034 and, for example, the channel frame 6036 of the end-effector6030, an impedance Z of the tissue 6032 changes. The lateral compressionor angular compressions 6054 and 6056 on either side of the RF electrode6048 may be caused by the end-effector 6030 and may be measured as afunction of different impedances Z of the tissue 6032, based on therelative positioning of the RF electrode 6048 and electrical contacts6050 and 6052.

In accordance with one or more of the techniques and features describedin the present disclosure, and as discussed above, an RF electrode maybe used as an RF sensor. Referring now to FIG. 27, in one aspect, an RFsensor 6062 may be positioned on a staple cartridge 6060 inserted into achannel frame 6066 an end-effector. The RF electrode may run from apower line 6064 which may be powered by a power source in a handle(e.g., handle 6002) of an endocutter.

Referring now to FIG. 28, in one aspect, RF electrodes 6074 and 6076 maybe positioned on a staple cartridge 6072 inserted into a channel frame6078 of end-effector 6070. As shown, RF electrode 6074 may be placed ina proximal position of the end-effector relative to an endocutterhandle. Further, RF electrode 6076 may be placed in a distal position ofthe end-effector relative to the endocutter handle. RF electrodes 6074and 6076 may be utilized to measure vertical, lateral, proximal, ordistal compression at different points in a tissue based on the positionof one or more electrical contacts on the end-effector.

Referring now to FIG. 29, in one aspect, RF electrodes 6084-6116 may bepositioned on staple cartridge 6082 inserted into the channel frame 6080(or other component of an end-effector) based on various points forwhich compression information is desired. Referring now to FIG. 30, inone aspect, RF electrodes 6122-6140 may be positioned on staplecartridge 6120 at discrete points for which compression information isdesired. Referring now to FIG. 31, RF electrodes 6152-6172 may bepositioned at different points in multiple zones of a staple cartridgebased on how accurate or precise the compression measurements should be.For example, RF electrodes 6152-6156 may be positioned in zone 6158 ofstaple cartridge 6150 depending on how accurate or precise thecompression measurements in zone 6158 should be. Further, RF electrodes6160-6164 may be positioned in zone 6166 of staple cartridge 6150depending on how accurate or precise the compression measurements inzone 6166 should be. Additionally, RF electrodes 6168-6172 may bepositioned in zone 6174 of staple cartridge 6150 depending on howaccurate or precise the compression measurements in zone 6174 should be.

The RF electrodes discussed herein may be wired through a staplecartridge inserted in the channel frame. Referring now to FIG. 32, inone aspect, an RF electrode may have a stamped “mushroom head” 6180 ofabout 1.0 mm in diameter. While the RF electrode may have the stamped“mushroom head” of about 1.0 mm in diameter, this is intended to be anon-limiting example and the RF electrode may be differently shaped andsized depending on each particular application or design. The RFelectrode may be connected to, fastened to, or may form, a conductivewire 6182. The conductive wire 6182 may be about 0.5 mm in diameter, ormay have a larger or smaller diameter based on a particular applicationor design. Further, the conductive wire may have an insulative coating6184. In one example, the RF electrode may protrude through a staplecartridge, channel frame, knife, or other component of an end-effector.

Referring now to FIG. 33, the RF electrodes may be wired through asingle wall or through multiple walls of a staple cartridge or channelframe of an end-effector. For example, RF electrodes 6190-6194 may bewired through wall 6196 of the staple cartridge or channel frame of anend-effector. One or more of wires 6198 may be connected to, fastenedto, or be part of, RF electrodes 6190-6194 and may run through wall 6196from a power source in, e.g., a handle of an endocutter.

Referring now to FIG. 34, the power source may be in communication withthe RF electrodes or may provide power to the RF electrodes through awire or cable. The wire or cable may join each individual wire and leadto the power source. For example, RF electrodes 6204-6212 may receivepower from a power source through wire or cable 6202, which may runthrough staple cartridge 6200 or a channel frame of an end-effector. Inone example, each of RF electrodes 6204-6212 may have its own wire thatruns to or through wire or cable 6202. The staple cartridge 6200 orchannel frame also may include a controller 6214, such as the primaryprocessor 2006 shown in connection with FIGS. 16A and 16B, or the maincontroller 3017 shown in connection with FIGS. 17A, 17B, and 18, forexample. It will be appreciated that the controller 6214 should besuitably sized to fit in the staple cartridge 6200 or channel frame formfactor.

In various aspects, the tissue compression sensor system describedherein for use with medical devices may include a frequency generator.The frequency generator may be located on a circuit board of the medicaldevice, such as an endocutter. For example the frequency generator maybe located on a circuit board in a shaft or handle of the endocutter.Referring now to FIG. 35, an example circuit diagram 6220 in accordancewith one example of the present disclosure is shown. As shown, frequencygenerator 6222 may receive power or current from a power source 6221 andmay supply one or more RF signals to one or more RF electrodes 6224. Asdiscussed above, the one or more RF electrodes may be positioned atvarious locations or components on an end-effector or endocutter, suchas a staple cartridge or channel frame. One or more electrical contacts,such as electrical contacts 6226 or 6228 may be positioned on a channelframe or an anvil of an end-effector. Further, one or more filters, suchas filters 6230 or 6232 may be communicatively coupled to the electricalcontacts 6226 or 6228 as shown in FIG. 35. The filters 6230 and 6232 mayfilter one or more RF signals supplied by the frequency generator 6222before joining a single return path 6234. A voltage V and a current Iassociated with the one or more RF signals may be used to calculate animpedance Z associated with a tissue that may be compressed and/orcommunicatively coupled between the one or more RF electrodes 6224 andthe electrical contacts 6226 or 6228.

Referring now to FIG. 36, various components of the tissue compressionsensor system described herein may be located in a handle 6236 of anendocutter. For example, as shown in circuit diagram 6220 a, frequencygenerator 6222 may be located in the handle 6236 and receives power frompower source 6221. Also, current I1 and current I2 may be measured on areturn path corresponding to electrical contacts 6228 and 6226. Using avoltage V applied between the supply and return paths, impedances Z1 andZ2 may be calculated. Z1 may correspond to an impedance of a tissuecompressed and/or communicatively coupled between one or more of RFelectrodes 6224 and electrical contact 6228. Further, Z2 may correspondto an impedance of a tissue compressed and/or communicatively coupledbetween one or more of RF electrodes 6224 and electrical contact 6226.Applying the formulas Z1=V/I1 and Z2=V/I2, impedances Z1 and Z2corresponding to different compression levels of a tissue compressed byan end-effector may be calculated.

Referring now to FIG. 37, one or more aspects of the present disclosureare described in circuit diagram 6250. In an implementation, a powersource at a handle 6252 of an endocutter may provide power to afrequency generator 6254. The frequency generator 6254 may generate oneor more RF signals. The one or more RF signals may be multiplexed oroverlaid at a multiplexer 6256, which may be in a shaft 6258 of theendocutter. In this way, two or more RF signals may be overlaid (or,e.g., nested or modulated together) and transmitted to the end-effector.The one or more RF signals may energize one or more RF electrodes 6260at an end-effector 6262 (e.g., positioned in a staple cartridge) of theendocutter. A tissue (not shown) may be compressed and/orcommunicatively coupled between the one or more of RF electrodes 6260and one or more electrical contacts. For example, the tissue may becompressed and/or communicatively coupled between the one or more RFelectrodes 6260 and the electrical contact 6264 positioned in a channelframe of the end-effector 6262 or the electrical contact 6266 positionedin an anvil of the end-effector 6262. A filter 6268 may becommunicatively coupled to the electrical contact 6264 and a filter 6270may be communicatively coupled to the electrical contact 6266.

A voltage V and a current I associated with the one or more RF signalsmay be used to calculate an impedance Z associated with a tissue thatmay be compressed between the staple cartridge (and communicativelycoupled to one or more RF electrodes 6260) and the channel frame oranvil (and communicatively coupled to one or more of electrical contacts6264 or 6266).

In one aspect, various components of the tissue compression sensorsystem described herein may be located in a shaft 6258 of theendocutter. For example, as shown in circuit diagram 6250 (and inaddition to the frequency generator 6254), an impedance calculator 6272,a controller 6274, a non-volatile memory 6276, and a communicationchannel 6278 may be located in the shaft 6258. In one example, thefrequency generator 6254, impedance calculator 6272, controller 6274,non-volatile memory 6276, and communication channel 6278 may bepositioned on a circuit board in the shaft 6258.

The two or more RF signals may be returned on a common path via theelectrical contacts. Further, the two or more RF signals may be filteredprior to the joining of the RF signals on the common path todifferentiate separate tissue impedances represented by the two or moreRF signals. Current I1 and current I2 may be measured on a return pathcorresponding to electrical contacts 6264 and 6266. Using a voltage Vapplied between the supply and return paths, impedances Z1 and Z2 may becalculated. Z1 may correspond to an impedance of a tissue compressedand/or communicatively coupled between one or more of RF electrodes 6260and electrical contact 6264. Further, Z2 may correspond to an impedanceof the tissue compressed and/or communicatively coupled between one ormore of RF electrodes 6260 and electrical contact 6266. Applying theformulas Z1=V/I1 and Z2=V/I2, impedances Z1 and Z2 corresponding todifferent compressions of a tissue compressed by an end-effector 6262may be calculated. In example, the impedances Z1 and Z2 may becalculated by the impedance calculator 6272. The impedances Z1 and Z2may be used to calculate various compression levels of the tissue.

In one aspect, filters 6268 and 6270 may be High Q filters such that thefilter range may be narrow (e.g., Q=10). Q may be defined by the Centerfrequency (Wo)/Bandwidth (BW) where Q=Wo/BW. In one example, Frequency 1may be 150 kHz and Frequency 2 may be 300 kHz. A viable impedancemeasurement range may be 100 kHz-20 MHz. In various examples, othersophisticated techniques, such as correlation, quadrature detection,etc., may be used to separate the RF signals.

Using one or more of the techniques and features described herein, asingle energized electrode on a staple cartridge or an isolated knife ofan end-effector may be used to make multiple tissue compressionmeasurements simultaneously. If two or more RF signals are overlaid ormultiplexed (or nested or modulated), they may be transmitted down asingle power side of the end-effector and may return on either thechannel frame or the anvil of the end-effector. If a filter were builtinto the anvil and channel contacts before they join a common returnpath, the tissue impedance represented by both paths could bedifferentiated. This may provide a measure of vertical tissue vs lateraltissue compression. This approach also may provide proximal and distaltissue compression depending on placement of the filters and location ofthe metallic return paths. A frequency generator and signal processormay be located on one or more chips on a circuit board or a sub board(which may already exist in an endocutter).

In various aspects, the present disclosure provides techniques formonitoring the speed and precision incrementing of the drive motor inthe surgical instrument 10 (described in connection with FIGS. 1-18). Inone example, a magnet can be placed on a planet frame of one of thestages of gear reduction with an inductance sensor on the gear housing.In another example, placing the magnet and magnetic field sensor on thelast stage would provide the most precise incremental movementmonitoring.

Conventional motor control systems employ encoders to detect thelocation and speed of the motor in hand held battery poweredendosurgical instruments such as powered endocutter/stapler devices.Precision operation of endocutter/stapler devices relies in part on theability to verify the motor operation under load. Simple sensorimplementations may be employed to achieve verify the motor operationunder load.

Accordingly, the present disclosure includes a magnetic body on one ofthe planetary carriers of a gear reduction system or employ brushlessmotor technology. Both approaches involve the placement of an inductancesensor on the outside housing of the motor or planetary gear system. Inthe case of a brushless motor there are electromagnetic field coils(windings, inductors, etc.) arrayed radially around the center magneticshaft of the motor. The coils are sequentially activated and deactivatedto drive the central motor shaft. One or more inductance sensors can beplaced outside of the motor and adjacent to at least some of the coilsto sense the activation/deactivation cycles of the motor windings todetermine the number times the shaft has been rotated. Alternatively, apermanent magnet can be placed on one of the planetary carriers and theinductance sensor can be placed adjacent to the radial path of theplanetary carrier to measure the number of times that stage of the geartrain is rotated. This implementation can be applied to any rotationalcomponents in the system with increasingly more resolution possible inregions with a relatively large number of rotations during function, oras the rotational components become closer (in terms of number ofconnections) to the end effector depending on the design. The gear trainsensing method may be preferred since it actually measures rotation ofone of the stages whereas the motor sensing method senses the number oftimes the motor has been commanded to energize, rather than the actualshaft rotation. For example, if the motor is stalled under high load,the motor sensing method would not be able to detect the lack ofrotation because it senses only the energizing cycles not shaftrotation. Nevertheless, both techniques can be employed in a costeffective manner to sense motor rotation.

During stapling, for example, tissue is firmly clamped between opposingjaws before a staple is driven into the clamped tissue. Tissuecompression during clamping can cause fluid to be displaced from thecompressed tissue, and the rate or amount of displacement variesdepending on tissue type, tissue thickness, the surgical operation(e.g., clamping pressure and clamping time). In various instances, fluiddisplacement between the opposing jaws of an end effector may contributeto malformation (e.g., bending) of staples between the opposing jaws.Accordingly, in various instances, it may be desirable to control thefiring stroke, e.g., to control the firing speed, in relationship to thedetected fluid flow, or lack thereof, intermediate opposing jaws of asurgical end effector.

Accordingly, also provided herein are methods, devices, and systems formonitoring speed and incremental movement of a surgical instrument drivetrain, which in turn provides information about the operational velocityof the device (e.g., jaw closure, stapling). In accordance with thepresent examples, the surgical instrument 10 (FIGS. 1-4) does notinclude a motor encoder. Rather, the surgical instrument 10 may beequipped with a motor comprising a speed sensor assembly for a powertrain of the motor, in accordance with an illustrative example. Thespeed sensor assembly can include a motor having an output shaft that iscoupled directly or indirectly to a drive shaft. In some examples, theoutput shaft is connected to a gear reduction assembly, such as aplanetary gear train comprising a sensor that detects the rotationalspeed of any suitable component of the system. For example, the sensormay be a proximity sensor, such as an induction sensor, which detectsmovement of one or more detectable elements affixed to any rotating partof the gear reduction assembly. The detectable element is affixed to thelast stage annular gear and the sensor is positioned adjacent the radialpath of the detectable element so as to detect movement of thedetectable element. Rotating components may vary depending on design—andthe sensor(s) can be affixed to any rotating component of the gearreduction assembly. For example, in another example, a detectableelement is associated with the carrier gear of the final stage or eventhe drive gear. In some examples, a detectable element is locatedoutside of the gear reduction assembly, such as on the driveshaftbetween gear reduction assembly and the end effector. In some example, adetectable element is located on a rotating component in the final gearreduction at the end effector.

Various functions may be implemented utilizing the circuitry previouslydescribed, For example, the motor may be controlled with a motorcontroller similar those described in connection with FIGS. 16A, 16B,17A, 17B, and 18, where the encoder is replaced with the monitoringspeed control and precision incrementing of motor systems for poweredsurgical instruments described herein.

In one aspect, the present disclosure provides a surgical instrument 10(described in connection with FIGS. 1-18) configured with varioussensing systems. Accordingly, for conciseness and clarity the details ofoperation and construction will not be repeated here. In one aspect, thesensing system includes a viscoelasticity/rate of change sensing systemto monitor knife acceleration, rate of change of impedance, and rate ofchange of tissue contact. In one example, the rate of change of knifeacceleration can be used as a measure of for tissue type. In anotherexample, the rate of change of impedance can be measures with a pulsesensor ad can be employed as a measure for compressibility. Finally, therate of change of tissue contact can be measured with a sensor based onknife firing rate to measure tissue flow.

The rate of change of a sensed parameter or stated otherwise, how muchtime is necessary for a tissue parameter to reach an asymptotic steadystate value, is a separate measurement in itself and may be morevaluable than the sensed parameter it was derived from. To enhancemeasurement of tissue parameters such as waiting a predetermined amountof time before making a measurement, the present disclosure provides anovel technique for employing the derivate of the measure such as therate of change of the tissue parameter.

The derivative technique or rate of change measure becomes most usefulwith the understanding that there is no single measurement that can beemployed alone to dramatically improve staple formation. It is thecombination of multiple measurements that make the measurements valid.In the case of tissue gap it is helpful to know how much of the jaw iscovered with tissue to make the gap measure relevant. Rate of changemeasures of impedance may be combined with strain measurements in theanvil to relate force and compression applied to the tissue graspedbetween the jaw members of the end effector such as the anvil and thestaple cartridge. The rate of change measure can be employed by theendosurgical device to determine the tissue type and not merely thetissue compression. Although stomach and lung tissue sometimes havesimilar thicknesses, and even similar compressive properties when thelung tissue is calcified, an instrument may be able to distinguish thesetissue types by employing a combination of measurements such as gap,compression, force applied, tissue contact area, and rate of change ofcompression or rate of change of gap. If any of these measurements wereused alone, the endosurgical it may be difficult for the endosurgicaldevice to distinguish one tissue type form another. Rate of change ofcompression also may be helpful to enable the device to determine if thetissue is “normal” or if some abnormality exists. Measuring not only howmuch time has passed but the variation of the sensor signals anddetermining the derivative of the signal would provide anothermeasurement to enable the endosurgical device to measure the signal.Rate of change information also may be employed in determining when asteady state has been achieved to signal the next step in a process. Forexample, after clamping the tissue between the jaw members of the endeffector such as the anvil and the staple cartridge, when tissuecompression reaches a steady state (e.g., about 15 seconds), anindicator or trigger to start firing the device can be enabled.

Also provided herein are methods, devices, and systems for timedependent evaluation of sensor data to determine stability, creep, andviscoelastic characteristics of tissue during surgical instrumentoperation. A surgical instrument 10, such as the stapler illustrated inFIG. 1, can include a variety of sensors for measuring operationalparameters, such as jaw gap size or distance, firing current, tissuecompression, the amount of the jaw that is covered by tissue, anvilstrain, and trigger force, to name a few. These sensed measurements areimportant for automatic control of the surgical instrument and forproviding feedback to the clinician.

The examples shown in connection with FIGS. 22A-37 may be employed tomeasure the various derived parameters such as gap distance versus time,tissue compression versus time, and anvil strain versus time. Motorcurrent may be monitored employing the current sensor 2312 in serieswith the battery 2308 as described herein, the current sensor 2412 inseries with the battery 2408 or the current sensor 3027 in FIG. 18.

FIG. 38 illustrates a motor-driven surgical instrument 8010 for cuttingand fastening that may or may not be reused. The surgical instrument8010 is similarly constructed and equipped as the surgical instrument 10for cutting and fastening described in connection with FIGS. 1-18. Inthe example illustrated in FIG. 38, the surgical instrument 8010includes a housing 8012 that comprises a handle assembly 8014 that isconfigured to be grasped, manipulated and actuated by the clinician. Thehousing 8012 is configured for operable attachment to an interchangeableshaft assembly 8200 that has an end effector 8300 operably coupledthereto that is configured to perform one or more surgical tasks orprocedures. Since the surgical instrument 8010 is similarly constructedand equipped as the surgical instrument 10 for cutting and fasteningdescribed in connection with FIGS. 1-18, for conciseness and clarity thedetails of operation and construction will not be repeated here.

The housing 8012 depicted in FIG. 38 is shown in connection with aninterchangeable shaft assembly 8200 that includes an end effector 8300that comprises a surgical cutting and fastening device that isconfigured to operably support a surgical staple cartridge 8304 therein.The housing 8012 may be configured for use in connection withinterchangeable shaft assemblies that include end effectors that areadapted to support different sizes and types of staple cartridges, havedifferent shaft lengths, sizes, and types, etc. In addition, the housing8012 also may be effectively employed with a variety of otherinterchangeable shaft assemblies including those assemblies that areconfigured to apply other motions and forms of energy such as, forexample, radio frequency (RF) energy, ultrasonic energy and/or motion toend effector arrangements adapted for use in connection with varioussurgical applications and procedures. Furthermore, the end effectors,shaft assemblies, handles, surgical instruments, and/or surgicalinstrument systems can utilize any suitable fastener, or fasteners, tofasten tissue. For instance, a fastener cartridge comprising a pluralityof fasteners removably stored therein can be removably inserted intoand/or attached to the end effector of a shaft assembly.

Turning now to FIG. 38, the surgical instrument 8010 is depicted thatmay or may not be reused. The surgical instrument 8010 is similarlyconstructed and equipped as the surgical instrument 10 for cutting andfastening described herein. In the example illustrated in FIG. 38, thesurgical instrument 8010 includes a housing 8012 that comprises a handleassembly 8014 that is configured to be grasped, manipulated and actuatedby the clinician. The housing 8012 is configured for operable attachmentto an interchangeable shaft assembly 8200 that has an end effector 8300operably coupled thereto that is configured to perform one or moresurgical tasks or procedures. Since the surgical instrument 8010 issimilarly constructed and equipped as the surgical instrument 10 forcutting and fastening described herein in connection with FIGS. 1-18,for conciseness and clarity the details of operation and constructionwill not be repeated here.

The housing 8012 depicted in FIG. 38 is shown in connection with aninterchangeable shaft assembly 8200 that includes an end effector 8300that comprises a surgical cutting and fastening device that isconfigured to operably support a surgical staple cartridge 8304 therein.The housing 8012 may be configured for use in connection withinterchangeable shaft assemblies that include end effectors that areadapted to support different sizes and types of staple cartridges, havedifferent shaft lengths, sizes, and types, etc. In addition, the housing8012 also may be effectively employed with a variety of otherinterchangeable shaft assemblies including those assemblies that areconfigured to apply other motions and forms of energy such as, forexample, radio frequency (RF) energy, ultrasonic energy and/or motion toend effector arrangements adapted for use in connection with varioussurgical applications and procedures. Furthermore, the end effectors,shaft assemblies, handles, surgical instruments, and/or surgicalinstrument systems can utilize any suitable fastener, or fasteners, tofasten tissue. For instance, a fastener cartridge comprising a pluralityof fasteners removably stored therein can be removably inserted intoand/or attached to the end effector of a shaft assembly.

FIG. 38 illustrates the surgical instrument 8010 with an interchangeableshaft assembly 8200 operably coupled thereto. In the illustratedarrangement, the handle housing forms a pistol grip portion 8019 thatcan be gripped and manipulated by the clinician. The handle assembly8014 operably supports a plurality of drive systems therein that areconfigured to generate and apply various control motions tocorresponding portions of the interchangeable shaft assembly that isoperably attached thereto. Trigger 8032 is operably associated with thepistol grip for controlling various of these control motions.

With continued reference to FIG. 38, the interchangeable shaft assembly8200 includes an end effector 8300 that comprises an elongated channel8302 that is configured to operably support a surgical staple cartridge8304 therein. The end effector 8300 may further include an anvil 8306that is pivotally supported relative to the elongated channel 8302.

The inventors have discovered that derived parameters can be even moreuseful for controlling a surgical instrument, such as the instrumentillustrated in FIG. 38, than the sensed parameter(s) upon which thederived parameter is based. Non-limiting examples of derived parametersinclude the rate of change of a sensed parameter (e.g., jaw gapdistance) and how much time elapses before a tissue parameter reaches anasymptotic steady state value (e.g., 15 seconds). Derived parameters,such as rate of change, are particularly useful because theydramatically improve measurement accuracy and also provide informationnot otherwise evident directly from sensed parameters. For example,impedance (i.e., tissue compression) rate of change can be combined withstrain in the anvil to relate compression and force, which enables thecontroller to determine the tissue type and not merely the amount oftissue compression. This example is illustrative only, and any derivedparameters can be combined with one or more sensed parameters to providemore accurate information about tissue types (e.g., stomach vs. lung),tissue health (calcified vs. normal), and operational status of thesurgical device (e.g., clamping complete). Different tissues have uniqueviscoelastic properties and unique rates of change, making these andother parameters discussed herein useful indicia for monitoring andautomatically adjusting a surgical procedure.

Specifically, referring to FIGS. 38 and 39, the gap 8040 is the distancebetween the anvil 8306 and the elongated channel 8302 of the endeffector 8300. In the open jaw position, at time zero, the gap 8040between the anvil 8306 and the elongated member is at its maximumdistance. The width of the gap 8040 decreases as the anvil 8306 closes,such as during tissue clamping. The gap distance rate of change can varybecause tissue has non-uniform resiliency. For example, certain tissuetypes may initially show rapid compression, resulting in a faster rateof change. However, as tissue is continually compressed, theviscoelastic properties of the tissue can cause the rate of change todecrease until the tissue cannot be compressed further, at which pointthe gap distance will remain substantially constant. The gap decreasesover time as the tissue is squeezed between the anvil 8306 and thesurgical staple cartridge 8304 of the end effector 8300. The one or moresensors described in connection with FIGS. 22A-37 and FIG. 40 may beadapted and configured to measure the gap distance “d” between the anvil8306 and the surgical staple cartridge 8304 over time t and the rate ofchange of the gap distance “d” over time t is the Slope of the curve,where Slope=Δd/Δt. In addition, the rate of change of firing current iscan be used as an indicator that the tissue is transitioning from onestate to another state. Accordingly, firing current and, in particular,the rate of change of firing current can be used to monitor deviceoperation. The firing current decreases over time as the knife cutsthrough the tissue. The rate of change of firing current can vary if thetissue being cut provides more or less resistance due to tissueproperties or sharpness of the knife 8305 (FIG. 39).For example, themotor current may be monitored employing the current sensor 2312 inseries with the battery 2308 as described herein, the current sensor2412 in series with the battery 2408 shown herein, or the current sensor3027 shown in FIG. 18. The current sensors 2312, 2314, 3027 may beadapted and configured to measure the motor firing current “i” over timet and the rate of change of the firing current “i” over time t is theSlope of the curve, where Slope=Δi/Δt. The sensors described inconnection with FIGS. 22A-37 and 40 may be adapted and configured tomeasure tissue compression/impedance. The sensors may be adapted andconfigured to measure tissue impedance “Z” over time t and the rate ofchange of the tissue impedance “Z” over time t is the Slope, whereSlope=ΔZ/Δt. The rate of change of anvil 8306 strain can be measured bya pressure sensor or strain gauge positioned on either or both the anvil8306 and the surgical staple cartridge 8304 (FIGS. 38, 39) to measurethe pressure or strain applied to the tissue grasped between the anvil8306 and the surgical staple cartridge 8304.Thus, at time zero, trigger8020 (FIG. 38) pressure may be at its lowest and trigger pressure mayincrease until completion of an operation (e.g., clamping, cutting, orstapling). The rate of change trigger force can be measured by apressure sensor or strain gauge positioned on the trigger 8032 of thepistol grip portion 8019 of the handle of the surgical instrument 8010(FIG. 38) to measure the force required to drive the knife 8305 (FIG.39) through the tissue grasped between the anvil 8306 and the surgicalstaple cartridge 8304.

Turning briefly to FIG. 40, the end effector 9012 is one aspect of theend effector 8300 (FIG. 38) that may be adapted to operate with surgicalinstrument 8010 (FIG. 38) to measure the various derived parameters suchas gap distance versus time, tissue compression versus time, and anvilstrain versus time. Accordingly, the end effector 9012 shown in FIG. 40may include one or more sensors configured to measure one or moreparameters or characteristics associated with the end effector 9012and/or a tissue section captured by the end effector 9012. In theexample illustrated in FIG. 40, the end effector 9012 comprises a firstsensor 9020 and a second sensor 9026. In various examples, the firstsensor 9020 and/or the second sensor 9026 may comprise, for example, amagnetic sensor such as, for example, a magnetic field sensor, a straingauge, a pressure sensor, a force sensor, an inductive sensor such as,for example, an eddy current sensor, a resistive sensor, a capacitivesensor, an optical sensor, and/or any other suitable sensor formeasuring one or more parameters of the end effector 9012.

In certain instances, the first sensor 9020 and/or the second sensor9026 may comprise, for example, a magnetic field sensor embedded in ananvil 9014 and configured to detect a magnetic field generated by amagnet 9024 embedded in a jaw member 9016 and/or the staple cartridge9018. The anvil 9014 is pivotally rotatable between open and closedpositions. The strength of the detected magnetic field may correspondto, for example, the thickness and/or fullness of a bite of tissuelocated between the anvil 9014 and the jaw member 9016. In certaininstances, the first sensor 9020 and/or the second sensor 9026 maycomprise a strain gauge, such as, for example, a micro-strain gauge,configured to measure the magnitude of the strain in the anvil 9014during a clamped condition. The strain gauge provides an electricalsignal whose amplitude varies with the magnitude of the strain.

In some aspects, one or more sensors of the end effector 9012 such as,for example, the first sensor 9020 and/or the second sensor 9026 maycomprise a pressure sensor configured to detect a pressure generated bythe presence of compressed tissue between the anvil 9014 and the jawmember 9016. In some examples, one or more sensors of the end effector9012 such as, for example, the first sensor 9020 and/or the secondsensor 9026 are configured to detect the impedance of a tissue sectionlocated between the anvil 9014 and the jaw member 9016. The detectedimpedance may be indicative of the thickness and/or fullness of tissuelocated between the anvil 9014 and the jaw member 9016.

In one aspect, one or more of the sensors of the end effector 9012 suchas, for example, the first sensor 9020 is configured to measure the gap9022 between the anvil 9014 and the jaw member 9016. In certaininstances, the gap 9022 can be representative of the thickness and/orcompressibility of a tissue section clamped between the anvil 9014 andthe jaw member 9016. In at least one example, the gap 9022 can be equal,or substantially equal, to the thickness of the tissue section clampedbetween the anvil 9014 and the jaw member 9016. In one example, one ormore of the sensors of the end effector 9012 such as, for example, thefirst sensor 9020 is configured to measure one or more forces exerted onthe anvil 9014 by the jaw member 9016 and/or tissue clamped between theanvil 9014 and the jaw member 9016. The forces exerted on the anvil 9014can be representative of the tissue compression experienced by thetissue section captured between the anvil 9014 and the jaw member 9016.In one aspect, the gap 9022 between the anvil 9014 and the jaw member9016 can be measured by positioning a magnetic field sensor on the anvil9014 and positioning a magnet on the jaw member 9016 such that the gap9022 is proportional to the signal detected by the magnetic field sensorand the signal is proportional to the distance between the magnet andthe magnetic field sensor. It will be appreciated that the location ofthe magnetic field sensor and the magnet may be swapped such that themagnetic field sensor is positioned on the jaw member 9016 and themagnet is placed on the anvil 9014.

One or more of the sensors such as, for example, the first sensor 9020and/or the second sensor 9026 may be measured in real-time during aclamping operation. Real -time measurement allows time based informationto be analyzed, for example, by a processor, and used to select one ormore algorithms and/or look-up tables for the purpose of assessing, inreal -time, a manual input of an operator of the surgical instrument9010. Furthermore, real -time feedback can be provided to the operatorto assist the operator in calibrating the manual input to yield adesired output.

FIG. 41 is a logic diagram illustrating one aspect of a real-timefeedback system 9060 for assessing, in real -time, a manual input 9064of an operator of the surgical instrument 9010 and providing to theoperator real -time feedback as to the adequacy of the manual input9064. With reference to FIGS. 40 and 41, in the example illustrated inFIG. 41, the real-time feedback system 9060 is comprised of a circuit.The circuit includes a controller 9061 comprising a processor 9062. Asensor such as, for example, the first sensor 9020 is employed by theprocessor 9062 to measure a parameter of the end effector 9012. Inaddition, the processor 9062 can be configured to determine or receive avalue representative of a manual input 9064 of an operator of thesurgical instrument 9010. The manual input 9064 can be continuouslyassessed by the processor 9062 for as long as the manual input 9064 isbeing provided by the operator. The processor 9062 can be configured tomonitor a value representative of the manual input 9064. Furthermore,the processor 9062 is configured to assign, select, or determine aposition, rank, and/or status for the determined value with respect to adesired zone or range. The measurement of the parameter of the endeffector 9012 and the determined value can be employed by the processor9062 to select or determine the position, rank, and/or status associatedwith the determined value, as described in greater detail below. Achange in the manual input 9064 yields a change in the determined valuewhich, in turn, yields a change in the position, rank, and/or statusassigned to the determined value with respect to the desired zone orrange.

As illustrated in FIG. 41, the real-time feedback system 9060 mayfurther include a feedback indicator 9066 which can be adjusted betweena plurality of positions, ranks, and/or statuses inside and outside adesired zone or range. In one example, the processor 9062 may select afirst position (P1), rank, and/or status that characterizes the manualinput 9064 based on a measurement (M1) of a parameter of the endeffector 9012 and a first determined value (V1) representing a firstmanual input (I1). In certain instances, the first position (P1), rank,and/or status may fall outside the desired zone or range. In suchinstances, the operator may change the manual input 9064 from the firstmanual input (I1) to a second manual input (I2) by increasing ordecreasing the manual input 9064, for example. In response, theprocessor 9062 may adjust the feedback indicator 9066 from the firstposition (P1), rank, and/or status to a second position (P2), rank,and/or status, which characterizes the change to the manual input 9064.The processor 9062 may select the second position (P2), rank, and/orstatus based on the measurement (M1) of the parameter of the endeffector 9012 and a second determined value (V2) representing a secondmanual input (I2). In certain instances, the second position (P2), rank,and/or status may fall inside the desired zone or range. In suchinstances, the operator may maintain the second manual input (I2) for aremainder of a treatment cycle or procedure, for example.

In the aspect illustrated in FIG. 41, the controller 9061 includes astorage medium such as, for example, a memory 9068. The memory 9068 maybe configured to store correlations between measurements of one or moreparameters of the end effector 9012, values representing manual inputs,and corresponding positions, ranks, and/or statuses characterizing themanual input 9064 with respect to a desired zone or range. In oneexample, the memory 9068 may store the correlation between themeasurement (M1), the first determined value (V1), and the first manualinput (I1), and the correlation between the measurement (M1), the seconddetermined value (V2), and the second manual input (I2). In one example,the memory 9068 may store an algorism, an equation, or a look-up tablefor determining correlations between measurements of one or moreparameters of the end effector 9012, values representing manual inputs,and corresponding positions, ranks, or statuses with respect to adesired zone or range. The processor 9062 may employ such algorism,equation, and/or look-up table to characterize a manual input 9064provided by an operator of the surgical instrument 9010 and providefeedback to the operator as to the adequacy of the manual input 9064.

FIG. 42 is a logic diagram illustrating one aspect of a real-timefeedback system 9070. The real-time feedback system 9070 is similar inmany respects to the real-time feedback system 9060. For example, likethe real-time feedback system 9060, the real-time feedback system 9070is configured for assessing, in real -time, a manual input of anoperator of the surgical instrument 9010 and providing to the operatorreal -time feedback as to the adequacy of the manual input. Furthermore,like the real-time feedback system 9060, the real-time feedback system9070 is comprised of a circuit that may include the controller 9061.

In the aspect illustrated in FIG. 42, a sensor 9072, such as, forexample, a strain gauge or a micro-strain gauge, is configured tomeasure one or more parameters of the end effector 9012, such as, forexample, the amplitude of the strain exerted on the anvil 9014 during aclamping operation, which can be indicative of the tissue compression.The measured strain is converted to a digital signal and provided to theprocessor 9062. A sensor 9074, such as, for example, a load sensor, canmeasure the force to advance the cutting member 9040 to cut tissuecaptured between the anvil 9014 and the staple cartridge 9018.Alternatively, a current sensor (not shown) can be employed to measurethe current drawn by the motor 9082. The force required to advance thefiring bar 9036 can correspond to the current drawn by the motor 9082,for example. The measured force is converted to a digital signal andprovided to the processor 9062. A sensor 9076, such as, for example, amagnetic field sensor, can be employed to measure the thickness of thecaptured tissue, as described above. The measurement of the magneticfield sensor 9076 is also converted to a digital signal and provided tothe processor 9062.

In the aspect illustrated in FIG. 42, the real-time feedback system 9070further includes the tracking system 9080 which can be configured todetermine the position of the firing trigger. As described above, thefiring trigger 9094 can be depressed or actuated by moving the firingtrigger 9094 between a plurality of positions, each corresponding to oneof a plurality of values of a characteristic of motion of the firing bar9036 and/or the cutting member 9040 during a firing stroke. As describeabove, a characteristic of motion can be a speed of advancement of thefiring bar 9036 and/or the cutting member 9040 during the firing stroke.In certain instances, a motor driver 9092 can be in communication withthe controller 9061, and can be configured to drive the motor 9082 inaccordance with an operator's manual input as detected by the trackingsystem 9080.

Further to the above, the real-time feedback system 9070 may include afeedback indicator 9066. In one aspect, the feedback indicator 9066 canbe disposed in the handle 9030. Alternatively, the feedback indicatorcan be disposed in the shaft assembly 9032, for example. In any event,the controller 9061 may employ the feedback indicator 9066 to providefeedback to an operator of the surgical instrument 9010 with regard tothe adequacy of a manual input such as, for example, a selected positionof the firing trigger 9094. To do so, the controller 9061 may assess theselected position of the firing trigger 9094 and/or the correspondingvalue of the speed of the firing bar 9036 and/or the cutting member9040. The measurements of the tissue compression, the tissue thickness,and/or the force required to advance the firing bar 9036, asrespectively measured by the sensors 9072, 9074, and 9076, can be usedby the controller 9061 to characterize the selected position of thefiring trigger 9094 and/or the corresponding value of the speed of thefiring bar 9036 and/or the cutting member 9040. In one instance, thememory 9068 may store an algorism, an equation, and/or a look-up tablewhich can be employed by the controller 9061 in the assessment. In oneexample, the measurements of the sensors 9072, 9074, and/or 9076 can beused to select or determine a position, rank, and/or a status thatcharacterizes the selected position of the firing trigger 9094 and/orthe corresponding value of the speed of the firing bar 9036 and/or thecutting member 9040. The determined position, rank, and/or status can becommunicated to the operator via the feedback indicator 9066.

The reader will appreciate that an optimal speed of the firing bar 9036and/or the cutting member 9040 during a firing stroke can depend onseveral parameters of the end effector 9012 such as, for example, thethickness of the tissue captured by the end effector 9012, the tissuecompression, and/or the force required to advance the firing bar 9036and, in turn, the cutting member 9040. As such, measurements of theseparameters can be leveraged by the controller 9061 in assessing whethera current speed of advancement of the cutting member 9040 through thecaptured tissue is within an optimal zone or range.

In one aspect, a plurality of smart sensors may be positioned on a powerline of an end-effector and may be communicatively coupled to a handleof an endocutter. The smart sensors may be positioned in series orparallel with respect to the power line. Referring now to FIG. 43, smartsensors 12060 and 12062 may be in communication with a signal processingcomponent or a processor 12064 which may be local to the smart sensors.Both the smart sensors 12060 and 12062 and the processor 12064 may belocated at the end-effector (represented by dashed-box 12066). Forexample, smart sensor 12060 may output signals or data to an operationalamplifier 12068 and an ADC converter 12070, which may condition thesignals or data for input into processor 12064. Similarly, smart sensor12062 may output signals or data to an operational amplifier 12072 andan ADC converter 12074, which may condition the signals or data forinput into processor 12064.

Smart sensors 12060 and/or 12062 may be different types of sensors orthe same type of sensor, which may be, for example, magnetic fieldsensors, magnetic sensors, inductive sensors, capacitive sensors, orother types of sensors used in medical devices or endocutters. Component12064, previously referred to as a processor, also may be acomputational core, FPGA (field programmable gate array), logic unit(e.g., logic processor or logic controller), signal processing unit, orother type of processor. The processor 12064 may be in communicationwith a memory, such as non-volatile memory 12076, which may storecalculation data, equipment information such as a type of cartridgeinserted in the end-effector 12066, tabular data, or other referencedata that may enable the processor 12064 to process signals or datareceived from one or more of the smart sensors 12060 or 12062 for use inoperating the end-effector 12066 or an endocutter.

Further, a shaft 12078 may include a return path through which at leastone of the plurality of smart sensors (e.g., smart sensors 12060 or12062) and the handle 12080 are communicatively coupled. The shaft mayinclude one or more wires which may transfer information from theprocessor 12064 to the handle 12080 for operation of the end-effector12066 or endocutter. In one example, the information from the processor12064 may be communicated to the handle 12080 (by way of shaft 12078 ordirectly without use of shaft 12078) over one or more of: a wired-line,a single-wired line, a multi-wired line, a wireless communicationprotocol such as Bluetooth, an optical line, or an acoustic line.

In one aspect, at least one of a plurality of smart sensors positionedat an end-effector may include a signal processing component. Forexample, the signal processing component may be built into the smartsensor or may be locally coupled to the smart sensor as a single module.The signal processing component may be configured to process datareceived from a sensor component (e.g., sensor component 12020) of atleast one of the plurality of smart sensors. A controller 12024 (e.g., acontroller) at the handle may be communicatively coupled to at least oneof the plurality of smart sensors.

In one aspect, a smart sensor may be configured for local signalprocessing in a medical device. The smart sensor may include at leastone sensor component (e.g., sensor component 12020) and at least oneprocessing component (e.g., processing component 12022). The processingcomponent may be configured to receive data from the at least one sensorcomponent and to process the data into information for use by themedical device. The medical device may be, for example, an endocutter,however this is not intended to be a limitation of the presentdisclosure. It should be understood that the techniques and featuresdiscussed herein for smart sensors with local signal processing may beused in any medical device where processing of sensor signals or data isused for operation of the medical device.

Further, a controller (e.g., controller 12024, controller) in themedical device may be configured to receive the information (i.e.,processed signals or data) from the at least one processing component(e.g., processing component 12022). As discussed above, the medicaldevice may be a surgical instrument such as an endocutter and the smartsensor may be configured for local signal processing in the surgicalinstrument. Local signal processing may refer to, for example,processing signals or data from a sensor component at a processingcomponent coupled to the sensor, where the resulting processedinformation may be used by a separate component. For example, thecontroller 12024 may be positioned in the handle 12012 of the surgicalinstrument (i.e., the endocutter 12010) and the smart sensor may beconfigured to be positioned in a separate component (i.e., theend-effector 12016) of the surgical instrument (i.e., the endocutter12010), separate from the handle 12012. Thus, the controller 12024 maybe positioned at the handle 12012 of the surgical instrument and thesignal processing component 12022 and the sensor 12020 may be located ina component separate from the handle 12012 (e.g., end-effector 12016).

In this way, the handle or controller 12024 need not have informationabout the smart sensor, knowledge of what the smart sensor is doing, orcapability to interpret data feed back from the smart sensor. This isbecause the processing component 12022 may transform or condition thedata from the smart sensor and generate information from the datadirectly usable by the handle or controller 12024. The informationgenerated by the processing component may be used directly, without thedata from the smart sensor needing to be processed in another part ofthe medical device (e.g., near the handle 12012 or controller 12024).Thus, the surgical instrument may be controlled based on the (processed)information from the signal processing component local to the sensor.

In one aspect, a current draw on a power line communicatively coupled tothe signal processing component 12022 (i.e., local to the sensor 12020)may be monitored. The current draw may be monitored by a processor,controller, or other monitoring device at the shaft 12014 or the handle12012, or at another processor, controller or other monitoring deviceseparate from the signal processing component 12022. For example, themonitoring may be a standard Morse Code type monitoring of the currentdraw on the power line. An issue with the surgical instrument based onthe current draw and a particular sensor may be determined by theseparate processor at, e.g., the handle 12012. In this way, themonitoring may allow the handle (or a processor or controller therein)to be informed of various issues related to signals or data received byone or more sensor and which particular sensor identified the issue,without a further communication requirement (e.g., pairing, or othercoupled communication).

FIG. 44 illustrates one aspect of a circuit 13190 configured to convertsignals from the first sensor 13158 and the plurality of secondarysensors 13160 a, 13160 b into digital signals receivable by a processor,such as, for example, the primary processor 2006 (FIGS. 16A-16B). Thecircuit 13190 comprises an analog-to-digital convertor 13194. In someexamples, the analog-to-digital convertor 13194 comprises a 4-channel,18-bit analog to digital convertor. Those skilled in the art willrecognize that the analog-to-digital convertor 13194 may comprise anysuitable number of channels and/or bits to convert one or more inputsfrom analog to digital signals. The circuit 13190 comprises one or morelevel shifting resistors 13196 configured to receive an input from thefirst sensor 13158, such as, for example, a magnetic field sensor. Thelevel shifting resistors 13196 adjust the input from the first sensor,shifting the value to a higher or lower voltage depending on the input.The level shifting resistors 13196 provide the level-shifted input fromthe first sensor 13158 to the analog-to-digital convertor.

In some aspects, a plurality of secondary sensors 13160 a, 13160 b arecoupled to a plurality of bridges 13192 a, 13192 b within the circuit13190. The plurality of bridges 13192 a, 13192 b may provide filteringof the input from the plurality of secondary sensors 13160 a, 13160 b.After filtering the input signals, the plurality of bridges 13192 a,13192 b provide the inputs from the plurality of secondary sensors 13160a, 13160 b to the analog-to-digital convertor 13194. In some examples, aswitch 13198 coupled to one or more level shifting resistors may becoupled to the analog-to-digital convertor 13194. The switch 13198 isconfigured to calibrate one or more of the input signals, such as, forexample, an input from a magnetic field sensor. The switch 13198 may beengaged to provide one or more level shifting signals to adjust theinput of one or more of the sensors, such as, for example, to calibratethe input of a magnetic field sensor. In some examples, the adjustmentis not necessary, and the switch 13198 is left in the open position todecouple the level shifting resistors. The switch 13198 is coupled tothe analog-to-digital convertor 13194. The analog-to-digital convertor13194 provides an output to one or more processors, such as, forexample, the primary processor 2006 (FIGS. 16A-16B). The primaryprocessor 2006 calculates one or more parameters of the end effector13150 based on the input from the analog-to-digital convertor 13194. Forexample, in one example, the primary processor 2006 calculates athickness of tissue located between the anvil 13152 and the staplecartridge 13156 based on inputs from the first sensor 13158 and theplurality of secondary sensors 13160 a, 13160 b.

FIG. 45 illustrates one aspect of a staple cartridge 13606 thatcomprises a flex cable 13630 connected to a magnetic field sensor 13610and processor 13612. The staple cartridge 13606 is similar to the staplecartridge 13606 is similar to the surgical staple cartridge 304 (FIG. 1)described above in connection with surgical instrument 10 (FIGS. 1-6).FIG. 112 is an exploded view of the staple cartridge 13606. The staplecartridge comprises 13606 a cartridge body 13620, a wedge sled 13618, acartridge tray 13622, and a flex cable 13630. The flex cable 13630further comprises electrical contacts 13632 at the proximal end of thestaple cartridge 13606, placed to make an electrical connection when thestaple cartridge 13606 is operatively coupled with an end effector, suchas end effector 13800 described below. The electrical contacts 13632 areintegrated with cable traces 13634, which extend along some of thelength of the staple cartridge 13606. The cable traces 13634 connect13636 near the distal end of the staple cartridge 13606 and thisconnection 13636 joins with a conductive coupling 13614. A magneticfield sensor 13610 and a processor 13612 are operatively coupled to theconductive coupling 13614 such that the magnetic field sensor 13610 andthe processor 13612 are able to communicate.

FIG. 46 illustrates one aspect of an end effector 13800 with a flexcable 13830 operable to provide power to a staple cartridge 13806 thatcomprises a distal sensor plug 13816. The end effector 13800 is similarto the end effector 300 (FIG. 1) described above in connection withsurgical instrument 10 (FIGS. 1-6). The end effector 13800 comprises ananvil 13802, a jaw member or elongated channel 13804, and a staplecartridge 13806 operatively coupled to the elongated channel 13804. Theend effector 13800 is operatively coupled to a shaft assembly. The shaftassembly is similar to interchangeable shaft assembly 200 (FIG. 1)described above in connection with surgical instrument 10 (FIGS. 1-6).The shaft assembly further comprises a closure tube that encloses theexterior of the shaft assembly. In some examples the shaft assemblyfurther comprises an articulation joint 13904, which includes a doublepivot closure sleeve assembly. The double pivot closure sleeve assemblyincludes an end effector closure sleeve assembly that is operable tocouple with the end effector 13800.

FIGS. 47 and 48 illustrate the elongated channel 13804 portion of theend effector 13800 without the anvil 13802 or the staple cartridge, toillustrate how the flex cable 13830 can be seated within the elongatedchannel 13804. In some examples, the elongated channel 13804 furthercomprises a third aperture 13824 for receiving the flex cable 13830.Within the body of the elongated channel 13804 the flex cable splits13834 to form extensions 13836 on either side of the elongated channel13804. FIG. 48 further illustrates that connectors 13838 can beoperatively coupled to the flex cable extensions 13836.

FIG. 49 illustrates the flex cable 13830 alone. As illustrated, the flexcable 13830 comprises a single coil 13832 operative to wrap around thearticulation joint 13904 (FIG. 46), and a split 13834 that attaches toextensions 13836. The extensions can be coupled to connectors 13838 thathave on their distal facing surfaces prongs 13840 for coupling to thestaple cartridge 13806, as described below.

FIG. 50 illustrates a close up view of the elongated channel 13804 shownin FIGS. 47 and 48 with a staple cartridge 13804 coupled thereto. Thestaple cartridge 13804 comprises a cartridge body 13822 and a cartridgetray 13820. In some examples the staple cartridge 13806 furthercomprises electrical traces 13828 that are coupled to proximal contacts13856 at the proximal end of the staple cartridge 13806. The proximalcontacts 13856 can be positioned to form a conductive connection withthe prongs 13840 of the connectors 13838 that are coupled to the flexcable extensions 13836. Thus, when the staple cartridge 13806 isoperatively coupled with the elongated channel 13804, the flex cable13830, through the connectors 13838 and the connector prongs 13840, canprovide power to the staple cartridge 13806.

FIGS. 51 and 52 illustrate one aspect of a distal sensor plug 13816.FIG. 51 illustrates a cutaway view of the distal sensor plug 13816. Asillustrated, the distal sensor plug 13816 comprises a magnetic fieldsensor 13810 and a processor 13812. The distal sensor plug 13816 furthercomprises a flex board 13814. As further illustrated in FIG. 52, themagnetic field sensor 13810 and the processor 13812 are operativelycoupled to the flex board 13814 such that they are capable ofcommunicating.

FIG. 53 illustrates one aspect of an end effector 13950 with a flexcable 13980 operable to provide power to sensors and electronics in thedistal tip 13952 of the anvil 13961 portion. The end effector 13950comprises an anvil 13961, a jaw member or elongated channel 13954, and astaple cartridge 13956 operatively coupled to the elongated channel. Theend effector 13950 is operatively coupled to a shaft assembly 13960. Theshaft assembly 13960 further comprises a closure tube 13962 thatencloses the shaft assembly 13960. In some examples the shaft assembly13960 further comprises an articulation joint 13964, which includes adouble pivot closure sleeve assembly 13966.

In various aspects, the end effector 13950 further comprises a flexcable 13980 that is configured to not interfere with the function of thearticulation joint 13964. In some examples, the closure tube 13962comprises a first aperture 13968 through which the flex cable 13980 canextend. In some examples, flex cable 13980 further comprises a loop orcoil 13982 that wraps around the articulation joint 13964 such that theflex cable 13980 does not interfere with the operation of thearticulation joint 13964, as further described below. In some examples,the flex cable 13980 extends along the length of the anvil 13961 to asecond aperture 13970 in the distal tip of the anvil 13961.

A portion of a surgical stapling instrument 16000 is illustrated inFIGS. 54-56. The stapling instrument 16000 is usable with amanually-operated system and/or a robotically-controlled system, forexample. The stapling instrument 16000 comprises a shaft 16010 and anend effector 16020 extending from the shaft 16010. The end effector16020 comprises a cartridge channel 16030 and a staple cartridge 16050positioned in the cartridge channel 16030. The staple cartridge 16050comprises a cartridge body 16051 and a retainer 16057 attached to thecartridge body 16051. The cartridge body 16051 is comprised of a plasticmaterial, for example, and the retainer 16057 is comprised of metal, forexample; however, the cartridge body 16051 and the retainer 16057 can becomprised of any suitable material. The cartridge body 16051 comprises adeck 16052 configured to support tissue, a longitudinal slot 16056, anda plurality of staple cavities 16053 defined in the deck 16052.

Referring primarily to FIGS. 55 and 56, staples 16055 are removablypositioned in the staple cavities 16053 and are supported by stapledrivers 16054 which are also movably positioned in the staple cavities16053. The retainer 16057 extends around the bottom of the cartridgebody 16051 to keep the staple drivers 16054 and/or the staples 16055from falling out of the bottom of the staple cavities 16053. The stapledrivers 16054 and the staples 16055 are movable between an unfiredposition (FIG. 55) and a fired position by a sled 16060. The sled 16060is movable between a proximal, unfired position (FIG. 55) toward adistal, fired position to eject the staples 16055 from the staplecartridge 16050, as illustrated in FIG. 56. The sled 16060 comprises oneor more ramped surfaces 16064 which are configured to slide under thestaple drivers 16054. The end effector 16020 further comprises an anvil16040 configured to deform the staples 16055 when the staples 16055 areejected from the staple cartridge 16050. In various instances, the anvil16040 can comprise forming pockets 16045 defined therein which areconfigured to deform the staples 16055.

The shaft 16010 comprises a frame 16012 and an outer sleeve 16014 whichis movable relative to the frame 16012. The cartridge channel 16030 ismounted to and extends from the shaft frame 16012. The outer sleeve16014 is operably engaged with the anvil 16040 and is configured to movethe anvil 16040 between an open position (FIG. 54) and a closed position(FIG. 55). In use, the anvil 16040 is movable toward a staple cartridge16050 positioned in the cartridge channel 16030 to clamp tissue againstthe deck 16052 of the staple cartridge 16050. In various alternativeaspects, the cartridge channel 16030 and the staple cartridge 16050 aremovable relative to the anvil 16040 to clamp tissue therebetween. Ineither event, the shaft 16010 further comprises a firing member 16070configured to push the sled 16060 distally. The firing member 16070comprises a knife edge 16076 which is movable within the longitudinalslot 16056 and is configured to incise the tissue positionedintermediate the anvil 16040 and the staple cartridge 16050 as thefiring member 16070 is advanced distally to eject the staples 16055 fromthe staple cartridge 16050. The firing member 16070 further comprises afirst cam 16071 configured to engage the cartridge channel 16030 and asecond cam 16079 configured to engage the anvil 16040 and hold the anvil16040 in position relative to the staple cartridge 16050. The first cam16071 is configured to slide under the cartridge channel 16030 and thesecond cam 16079 is configured to slide within an elongated slot 16049defined in the anvil 16040.

FIG. 57 illustrates one aspect of an end effector 3011 comprising afirst sensor 3008 a and a second sensor 3008 b. The end effector 3011 issimilar to the end effector 300 described above. The end effector 3011comprises an anvil 3013 pivotally coupled to a jaw member 3004. The jawmember 3004 is configured to receive a staple cartridge 3021 therein.The staple cartridge 3021 comprises a plurality of staples (not shown).The plurality of staples is deployable from the staple cartridge 3021during a surgical operation. The end effector 3011 comprises a firstsensor 3008 a configured to measure one or more parameters of the endeffector 3011. For example, in one aspect, the first sensor 3008 a isconfigured to measure the gap 3023 between the anvil 3013 and the jawmember 3004. The first sensor 3008 a may comprise, for example, a Halleffect sensor configured to detect a magnetic field generated by amagnet 3012 embedded in the second jaw member 3004 and/or the staplecartridge 3021. As another example, in one aspect, the first sensor 3008a is configured to measure one or more forces exerted on the anvil 3013by the second jaw member 3004 and/or tissue clamped between the anvil3013 and the second jaw member 3004.

The end effector 3011 comprises a second sensor 3008 b. The secondsensor 3008 b is configured to measure one or more parameters of the endeffector 3011. For example, in various aspects, the second sensor 3008 bmay comprise a strain gauge configured to measure the magnitude of thestrain in the anvil 3013 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. In various aspects, the first sensor 3008 a and/or thesecond sensor 3008 b may comprise, for example, a magnetic sensor suchas, for example, a Hall effect sensor, a strain gauge, a pressuresensor, a force sensor, an inductive sensor such as, for example, aneddy current sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 3011. The first sensor 3008 a and thesecond sensor 3008 b may be arranged in a series configuration and/or aparallel configuration. In a series configuration, the second sensor3008 b may be configured to directly affect the output of the firstsensor 3008 a. In a parallel configuration, the second sensor 3008 b maybe configured to indirectly affect the output of the first sensor 3008a.

In one aspect, the one or more parameters measured by the first sensor3008 a are related to the one or more parameters measured by the secondsensor 3008 b. For example, in one aspect, the first sensor 3008 a isconfigured to measure the gap 3023 between the anvil 3013 and the jawmember 3004. The gap 3023 is representative of the thickness and/orcompressibility of a tissue section clamped between the anvil 3013 andthe staple cartridge 3021 located in the jaw member 3004. The firstsensor 3008 a may comprise, for example, a Hall effect sensor configuredto detect a magnetic field generated by a magnet 3012 coupled to thesecond jaw member 3004 and/or the staple cartridge 3021. Measuring at asingle location accurately describes the compressed tissue thickness fora calibrated full bit of tissue, but may provide inaccurate results whena partial bite of tissue is placed between the anvil 3013 and the secondjaw member 3004. A partial bite of tissue, either a proximal partialbite or a distal partial bite, changes the clamping geometry of theanvil 3013.

In some aspects, the second sensor 3008 b is configured to detect one ormore parameters indicative of a type of tissue bite, for example, a fullbite, a partial proximal bite, and/or a partial distal bite. Themeasurement of the second sensor 3008 b may be used to adjust themeasurement of the first sensor 3008 a to accurately represent aproximal or distal positioned partial bite's true compressed tissuethickness. For example, in one aspect, the second sensor 3008 bcomprises a strain gauge, such as, for example, a micro-strain gauge,configured to monitor the amplitude of the strain in the anvil during aclamped condition. The amplitude of the strain of the anvil 3013 is usedto modify the output of the first sensor 3008 a, for example, a Halleffect sensor, to accurately represent a proximal or distal positionedpartial bite's true compressed tissue thickness. The first sensor 3008 aand the second sensor 3008 b may be measured in real-time during aclamping operation. Real-time measurement allows time based informationto be analyzed, for example, by the primary processor 2006, and used toselect one or more algorithms and/or look-up tables to recognize tissuecharacteristics and clamping positioning to dynamically adjust tissuethickness measurements.

In some aspects, the thickness measurement of the first sensor 3008 amay be provided to an output device of a surgical instrument 10 coupledto the end effector 3011. For example, in one aspect, the end effector3011 is coupled to the surgical instrument 10 comprising a display 2028.The measurement of the first sensor 3008 a is provided to a processor,for example, the primary processor 2006. The primary processor 2006adjusts the measurement of the first sensor 3008 a based on themeasurement of the second sensor 3008 b to reflect the true tissuethickness of a tissue section clamped between the anvil 3013 and thestaple cartridge 3021. The primary processor 2006 outputs the adjustedtissue thickness measurement and an indication of full or partial biteto the display 2028. An operator may determine whether or not to deploythe staples in the staple cartridge 3021 based on the displayed values.

In some aspects, the first sensor 3008 a and the second sensor 3008 bmay be located in different environments, such as, for example, thefirst sensor 3008 a being located within a patient at a treatment siteand the second sensor 3008 b being located externally to the patient.The second sensor 3008 b may be configured to calibrate and/or modifythe output of the first sensor 3008 a. The first sensor 3008 a and/orthe second sensor 3008 b may comprise, for example, an environmentalsensor. Environmental sensors may comprise, for example, temperaturesensors, humidity sensors, pressure sensors, and/or any other suitableenvironmental sensor.

FIG. 58 is a logic diagram illustrating one aspect of a process 3050 fordetermining and displaying the thickness of a tissue section clampedbetween the anvil 3013 and the staple cartridge 3021 of the end effector3011. The process 3050 comprises obtaining a Hall effect voltage 3052,for example, through a Hall effect sensor located at the distal tip ofthe anvil 3013. The Hall effect voltage 3052 is provided to an analog todigital convertor 3054 and converted into a digital signal. The digitalsignal is provided to a processor, such as, for example, the primaryprocessor 2006. The primary processor 2006 calibrates 3056 the curveinput of the Hall effect voltage 3052 signal. A strain gauge 3058, suchas, for example, a micro-strain gauge, is configured to measure one ormore parameters of the end effector 3011, such as, for example, theamplitude of the strain exerted on the anvil 3013 during a clampingoperation. The measured strain is converted 3060 to a digital signal andprovided to the processor, such as, for example, the primary processor2006. The primary processor 2006 uses one or more algorithms and/orlookup tables to adjust the Hall effect voltage 3052 in response to thestrain measured by the strain gauge 3058 to reflect the true thicknessand fullness of the bite of tissue clamped by the anvil 3013 and thestaple cartridge 3021. The adjusted thickness is displayed 3026 to anoperator by, for example, a display 2026 embedded in the surgicalinstrument 10.

In some aspects, the surgical instrument can further comprise a loadsensor 3082 or load cell. The load sensor 3082 can be located, forinstance, in the interchangeable shaft assembly 200, described above, orin the housing 12, also described above.

FIG. 59 is a logic diagram illustrating one aspect of a process 3070 fordetermining and displaying the thickness of a tissue section clampedbetween the anvil 3013 and the staple cartridge 3021 of the end effector3011. The process comprises obtaining a Hall effect voltage 3072, forexample, through a Hall effect sensor located at the distal tip of theanvil 3013. The Hall effect voltage 3072 is provided to an analog todigital convertor 3074 and converted into a digital signal. The digitalsignal is provided to a processor, such as, for example, the primaryprocessor 2006. The primary processor 2006 applies calibrates 3076 thecurve input of the Hall effect voltage 3072 signal. A strain gauge 3078,such as, for example, a micro-strain gauge, is configured to measure oneor more parameters of the end effector 3011, such as, for example, theamplitude of the strain exerted on the anvil 3013 during a clampingoperation. The measured strain is converted 3080 to a digital signal andprovided to the processor, such as, for example, the primary processor2006. The load sensor 3082 measures the clamping force of the anvil 3013against the staple cartridge 3021. The measured clamping force isconverted 3084 to a digital signal and provided to the processor, suchas for example, the primary processor 2006. The primary processor 2006uses one or more algorithms and/or lookup tables to adjust the Halleffect voltage 3072 in response to the strain measured by the straingauge 3078 and the clamping force measured by the load sensor 3082 toreflect the true thickness and fullness of the bite of tissue clamped bythe anvil 3013 and the staple cartridge 3021. The adjusted thickness isdisplayed 3026 to an operator by, for example, a display 2026 embeddedin the surgical instrument 10.

FIG. 60 illustrates one aspect of an end effector 3100 comprising afirst sensor 3108 a and a second sensor 3108 b. The end effector 3100 issimilar to the end effector 3011. The end effector 3100 comprises aanvil, or anvil, 3102 pivotally coupled to a jaw member 3104. The jawmember 3104 is configured to receive a staple cartridge 3106 therein.The end effector 3100 comprises a first sensor 3108 a coupled to theanvil 3102. The first sensor 3108 a is configured to measure one or moreparameters of the end effector 3100, such as, for example, the gap 3110between the anvil 3102 and the staple cartridge 3106. The gap 3110 maycorrespond to, for example, a thickness of tissue clamped between theanvil 3102 and the staple cartridge 3106. The first sensor 3108 a maycomprise any suitable sensor for measuring one or more parameters of theend effector. For example, in various aspects, the first sensor 3108 amay comprise a magnetic sensor, such as a Hall effect sensor, a straingauge, a pressure sensor, an inductive sensor, such as an eddy currentsensor, a resistive sensor, a capacitive sensor, an optical sensor,and/or any other suitable sensor.

In some aspects, the end effector 3100 comprises a second sensor 3108 b.The second sensor 3108 b is coupled to jaw member 3104 and/or the staplecartridge 3106. The second sensor 3108 b is configured to detect one ormore parameters of the end effector 3100. For example, in some aspects,the second sensor 3108 b is configured to detect one or more instrumentconditions such as, for example, a color of the staple cartridge 3106coupled to the jaw member 3104, a length of the staple cartridge 3106, aclamping condition of the end effector 3100, the number of uses/numberof remaining uses of the end effector 3100 and/or the staple cartridge3106, and/or any other suitable instrument condition. The second sensor3108 b may comprise any suitable sensor for detecting one or moreinstrument conditions, such as, for example, a magnetic sensor, such asa Hall effect sensor, a strain gauge, a pressure sensor, an inductivesensor, such as an eddy current sensor, a resistive sensor, a capacitivesensor, an optical sensor, and/or any other suitable sensor.

In one aspect, input from the second sensor 3108 b may be used tocalibrate the input of the first sensor 3108 a. The second sensor 3108 bmay be configured to detect one or more parameters of the staplecartridge 3106, such as, for example, the color and/or length of thestaple cartridge 3106. The detected parameters, such as the color and/orthe length of the staple cartridge 3106, may correspond to one or moreproperties of the cartridge, such as, for example, the height of thecartridge deck, the thickness of tissue useable/optimal for the staplecartridge, and/or the pattern of the staples in the staple cartridge3106. The known parameters of the staple cartridge 3106 may be used toadjust the thickness measurement provided by the first sensor 3108 a.For example, if the staple cartridge 3106 has a higher deck height, thethickness measurement provided by the first sensor 3108 a may be reducedto compensate for the added deck height. The adjusted thickness may bedisplayed to an operator, for example, through a display 2026 coupled tothe surgical instrument 10.

FIG. 61 illustrates one aspect of an end effector 3150 comprising afirst sensor 3158 and a plurality of secondary sensors 3160 a, 3160 b.The end effector 3150 comprises a anvil, or anvil, 3152 and a jaw member3154. The jaw member 3154 is configured to receive a staple cartridge3156. The anvil 3152 is pivotally moveable with respect to the jawmember 3154 to clamp tissue between the anvil 3152 and the staplecartridge 3156. The anvil comprises a first sensor 3158. The firstsensor 3158 is configured to detect one or more parameters of the endeffector 3150, such as, for example, the gap 3110 between the anvil 3152and the staple cartridge 3156. The gap 3110 may correspond to, forexample, a thickness of tissue clamped between the anvil 3152 and thestaple cartridge 3156. The first sensor 3158 may comprise any suitablesensor for measuring one or more parameters of the end effector. Forexample, in various aspects, the first sensor 3158 may comprise amagnetic sensor, such as a Hall effect sensor, a strain gauge, apressure sensor, an inductive sensor, such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor.

In some aspects, the end effector 3150 comprises a plurality ofsecondary sensors 3160 a, 3160 b. The secondary sensors 3160 a, 3160 bare configured to detect one or more parameters of the end effector3150. For example, in some aspects, the secondary sensors 3160 a, 3160 bare configured to measure an amplitude of strain exerted on the anvil3152 during a clamping procedure. In various aspects, the secondarysensors 3160 a, 3160 b may comprise a magnetic sensor, such as a Halleffect sensor, a strain gauge, a pressure sensor, an inductive sensor,such as an eddy current sensor, a resistive sensor, a capacitive sensor,an optical sensor, and/or any other suitable sensor. The secondarysensors 3160 a, 3160 b may be configured to measure one or moreidentical parameters at different locations of the anvil 3152, differentparameters at identical locations on the anvil 3152, and/or differentparameters at different locations on the anvil 3152.

FIG. 62 illustrates one aspect of an end effector 3200 comprising aplurality of sensors 3208 a-3208 d. The end effector 3200 comprises ananvil 3202 pivotally coupled to a jaw member 3204. The jaw member 3204is configured to receive a staple cartridge 3206 therein. The anvil 3202comprises a plurality of sensors 3208 a-3208 d thereon. The plurality ofsensors 3208 a-3208 d is configured to detect one or more parameters ofthe end effector 3200, such as, for example, the anvil 3202. Theplurality of sensors 3208 a-3208 d may comprise one or more identicalsensors and/or different sensors. The plurality of sensors 3208 a-3208 dmay comprise, for example, magnetic sensors, such as a Hall effectsensor, strain gauges, pressure sensors, inductive sensors, such as aneddy current sensor, resistive sensors, capacitive sensors, opticalsensors, and/or any other suitable sensors or combination thereof. Forexample, in one aspect, the plurality of sensors 3208 a-3208 d maycomprise a plurality of strain gauges.

In one aspect, the plurality of sensors 3208 a-3208 d allows a robusttissue thickness sensing process to be implemented. By detecting variousparameters along the length of the anvil 3202, the plurality of sensors3208 a-3208 d allow a surgical instrument, such as, for example, thesurgical instrument 10, to calculate the tissue thickness in the jawsregardless of the bite, for example, a partial or full bite. In someaspects, the plurality of sensors 3208 a-3208 d comprises a plurality ofstrain gauges. The plurality of strain gauges is configured to measurethe strain at various points on the anvil 3202. The amplitude and/or theslope of the strain at each of the various points on the anvil 3202 canbe used to determine the thickness of tissue in between the anvil 3202and the staple cartridge 3206. The plurality of strain gauges may beconfigured to optimize maximum amplitude and/or slope differences basedon clamping dynamics to determine thickness, tissue placement, and/ormaterial properties of the tissue. Time based monitoring of theplurality of sensors 3208 a-3208 d during clamping allows a processor,such as, for example, the primary processor 2006, to utilize algorithmsand look-up tables to recognize tissue characteristics and clampingpositions and dynamically adjust the end effector 3200 and/or tissueclamped between the anvil 3202 and the staple cartridge 3206.

FIG. 63 is a logic diagram illustrating one aspect of a process 3220 fordetermining one or more tissue properties based on a plurality ofsensors 3208 a-3208 d. In one aspect, a plurality of sensors 3208 a-3208d generate 3222 a-3222 d a plurality of signals indicative of one ormore parameters of the end effector 3200. The plurality of generatedsignals is converted 3224 a-3224 d to digital signals and provided to aprocessor. For example, in one aspect comprising a plurality of straingauges, a plurality of electronic μStrain (micro-strain) conversioncircuits convert 3224 a-3224 d the strain gauge signals to digitalsignals. The digital signals are provided to a processor, such as, forexample, the primary processor 2006. The primary processor 2006determines 3226 one or more tissue characteristics based on theplurality of signals. The primary processor 2006 may determine the oneor more tissue characteristics by applying an algorithm and/or a look-uptable. The one or more tissue characteristics are displayed 3026 to anoperator, for example, by a display 2026 embedded in the surgicalinstrument 10.

FIG. 64 illustrates one aspect of an end effector 3250 comprising aplurality of secondary sensors 3260 a-3260 d coupled to a jaw member3254. The end effector 3250 comprises an anvil 3252 pivotally coupled toa jaw member 3254. The anvil 3252 is moveable relative to the jaw member3254 to clamp one or more materials, such as, for example, a tissuesection 3264, therebetween. The jaw member 3254 is configured to receivea staple cartridge 3256. A first sensor 3258 is coupled to the anvil3252. The first sensor is configured to detect one or more parameters ofthe end effector 3150, such as, for example, the gap 3110 between theanvil 3252 and the staple cartridge 3256. The gap 3110 may correspondto, for example, a thickness of tissue clamped between the anvil 3252and the staple cartridge 3256. The first sensor 3258 may comprise anysuitable sensor for measuring one or more parameters of the endeffector. For example, in various aspects, the first sensor 3258 maycomprise a magnetic sensor, such as a Hall effect sensor, a straingauge, a pressure sensor, an inductive sensor, such as an eddy currentsensor, a resistive sensor, a capacitive sensor, an optical sensor,and/or any other suitable sensor.

A plurality of secondary sensors 3260 a-3260 d is coupled to the jawmember 3254. The plurality of secondary sensors 3260 a-3260 d may beformed integrally with the jaw member 3254 and/or the staple cartridge3256. For example, in one aspect, the plurality of secondary sensors3260 a-3260 d is disposed on an outer row of the staple cartridge 3256(see FIG. 63). The plurality of secondary sensors 3260 a-3260 d areconfigured to detect one or more parameters of the end effector 3250and/or a tissue section 3264 clamped between the anvil 3252 and thestaple cartridge 3256. The plurality of secondary sensors 3260 a-3260 dmay comprise any suitable sensors for detecting one or more parametersof the end effector 3250 and/or the tissue section 3264, such as, forexample, magnetic sensors, such as a Hall effect sensor, strain gauges,pressure sensors, inductive sensors, such as an eddy current sensor,resistive sensors, capacitive sensors, optical sensors, and/or any othersuitable sensors or combination thereof. The plurality of secondarysensors 3260 a-3260 d may comprise identical sensors and/or differentsensors.

In some aspects, the plurality of secondary sensors 3260 a-3260 dcomprises dual purpose sensors and tissue stabilizing elements. Theplurality of secondary sensors 3260 a-3260 d comprise electrodes and/orsensing geometries configured to create a stabilized tissue conditionwhen the plurality of secondary sensors 3260 a-3260 d are engaged with atissue section 3264, such as, for example, during a clamping operation.In some aspects, one or more of the plurality of secondary sensors 3260a-3260 d may be replaced with non-sensing tissue stabilizing elements.The secondary sensors 3260 a-3260 d create a stabilized tissue conditionby controlling tissue flow, staple formation, and/or other tissueconditions during a clamping, stapling, and/or other treatment process.

FIG. 65 illustrates one aspect of a staple cartridge 3270 comprising aplurality of sensors 3272 a-3272 h formed integrally therein. The staplecartridge 3270 comprises a plurality of rows containing a plurality ofholes for storing staples therein. One or more of the holes in the outerrow 3278 are replaced with one of the plurality of sensors 3272 a-3272h. A cut-away section 3274 is shown to illustrate a sensor 3272 fcoupled to a sensor wire 3276 b. The sensor wires 3276 a, 3276 b maycomprise a plurality of wires for coupling the plurality of sensors 3272a-3272 h to one or more circuits of a surgical instrument, such as, forexample, the surgical instrument 10. In some aspects, one or more of theplurality of sensors 3272 a-3272 h comprise dual purpose sensor andtissue stabilizing elements having electrodes and/or sensing geometriesconfigured to provide tissue stabilization. In some aspects, theplurality of sensors 3272 a-3272 h may be replaced with and/orco-populated with a plurality of tissue stabilizing elements. Tissuestabilization may be provided by, for example, controlling tissue flowand/or staple formation during a clamping and/or stapling process. Theplurality of sensors 3272 a-3272 h provide signals to one or morecircuits of the surgical instrument 10 to enhance feedback of staplingperformance and/or tissue thickness sensing.

FIG. 66 is a logic diagram illustrating one aspect of a process 3280 fordetermining one or more parameters of a tissue section 3264 clampedwithin an end effector, such as, for example, the end effector 3250illustrated in FIG. 64. In one aspect, a first sensor 3258 is configuredto detect one or more parameters of the end effector 3250 and/or atissue section 3264 located between the anvil 3252 and the staplecartridge 3256. A first signal is generated 3282 by the first sensors3258. The first signal is indicative of the one or more parametersdetected by the first sensor 3258. One or more secondary sensors 3260are configured to detect one or more parameters of the end effector 3250and/or the tissue section 3264. The secondary sensors 3260 may beconfigured to detect the same parameters, additional parameters, ordifferent parameters as the first sensor 3258. Secondary signals 3284are generated by the secondary sensors 3260. The secondary signals 3284are indicative of the one or more parameters detected by the secondarysensors 3260. The first signal and the secondary signals are provided toa processor, such as, for example, a primary processor 2006. The primaryprocessor 2006 adjusts 3286 the first signal generated by the firstsensor 3258 based on input generated by the secondary sensors 3260. Theadjusted signal may be indicative of, for example, the true thickness ofa tissue section 3264 and the fullness of the bite. The adjusted signalis displayed 3026 to an operator by, for example, a display 2026embedded in the surgical instrument 10.

FIG. 67 illustrates one aspect of an end effector 3350 comprising amagnetic sensor 3358 comprising a specific sampling rate to limit oreliminate false signals. The end effector 3350 comprises a anvil, oranvil, 3352 pivotably coupled to a jaw member 3354. The jaw member 3354is configured to receive a staple cartridge 3356 therein. The staplecartridge 3356 contains a plurality of staples that may be delivered toa tissue section located between the anvil 3352 and the staple cartridge3356. A magnetic sensor 3358 is coupled to the anvil 3352. The magneticsensor 3358 is configured to detect one or more parameters of the endeffector 3350, such as, for example, the gap 3364 between the anvil 3352and the staple cartridge 3356. The gap 3364 may correspond to thethickness of a material, such as, for example, a tissue section, and/orthe fullness of a bite of material located between the anvil 3352 andthe staple cartridge 3356. The magnetic sensor 3358 may comprise anysuitable sensor for detecting one or more parameters of the end effector3350, such as, for example, a magnetic sensor, such as a Hall effectsensor, a strain gauge, a pressure sensor, an inductive sensor, such asan eddy current sensor, a resistive sensor, a capacitive sensor, anoptical sensor, and/or any other suitable sensor.

In one aspect, the magnetic sensor 3358 comprises a magnetic sensorconfigured to detect a magnetic field generated by an electromagneticsource 3360 coupled to the jaw member 3354 and/or the staple cartridge3356. The electromagnetic source 3360 generates a magnetic fielddetected by the magnetic sensor 3358. The strength of the detectedmagnetic field may correspond to, for example, the thickness and/orfullness of a bite of tissue located between the anvil 3352 and thestaple cartridge 3356. In some aspects, the electromagnetic source 3360generates a signal at a known frequency, such as, for example, 1 MHz. Inother aspects, the signal generated by the electromagnetic source 3360may be adjustable based on, for example, the type of staple cartridge3356 installed in the jaw member 3354, one or more additional sensor, analgorithm, and/or one or more parameters.

In one aspect, a signal processor 3362 is coupled to the end effector3350, such as, for example, the anvil 3352. The signal processor 3362 isconfigured to process the signal generated by the magnetic sensor 3358to eliminate false signals and to boost the input from the magneticsensor 3358. In some aspects, the signal processor 3362 may be locatedseparately from the end effector 3350, such as, for example, in thehandle assembly 14 of a surgical instrument 10. In some aspects, thesignal processor 3362 is formed integrally with and/or comprises analgorithm executed by a general processor, such as, for example, theprimary processor 2006. The signal processor 3362 is configured toprocess the signal from the magnetic sensor 3358 at a frequencysubstantially equal to the frequency of the signal generated by theelectromagnetic source 3360. For example, in one aspect, theelectromagnetic source 3360 generates a signal at a frequency of 1 MHz.The signal is detected by the magnetic sensor 3358. The magnetic sensor3358 generates a signal indicative of the detected magnetic field whichis provided to the signal processor 3362. The signal is processed by thesignal processor 3362 at a frequency of 1 MHz to eliminate falsesignals. The processed signal is provided to a processor, such as, forexample, the primary processor 2006. The primary processor 2006correlates the received signal to one or more parameters of the endeffector 3350, such as, for example, the gap 3364 between the anvil 3352and the staple cartridge 3356.

FIG. 68 is a logic diagram illustrating one aspect of a process 3370 forgenerating a thickness measurement for a tissue section located betweenan anvil and a staple cartridge of an end effector, such as, forexample, the end effector 3350 illustrated in FIG. 45. In one aspect ofthe process 3370, a signal is generated 3372 by a modulatedelectromagnetic source 3360. The generated signal may comprise, forexample, a 1MHz signal. A magnetic sensor 3358 is configured to detect3374 the signal generated by the electromagnetic source 3360. Themagnetic sensor 3358 generates a signal indicative of the detectedmagnetic field and provides the signal to a signal processor 3362. Thesignal processor 3362 processes 3376 the signal to remove noise, falsesignals, and/or to boost the signal. The processed signal is provided toan analog-to-digital convertor for conversion 3378 to a digital signal.Calibration 3380 of the digital signal may be performed, for example, byapplication of a calibration curve input algorithm and/or look-up table.The processes 3376, conversion 3378, and calibration 3380 may beperformed by one or more circuits. The calibrated signal is displayed3026 to a user by, for example, a display 2026 formed integrally withthe surgical instrument 10.

FIGS. 69A and 69B illustrate one aspect of an end effector 3800comprising a pressure sensor. The end effector 3800 comprises a anvil,or anvil, 3802 pivotally coupled to a jaw member 3804. The jaw member3804 is configured to receive a staple cartridge 3806 therein. Thestaple cartridge 3806 comprises a plurality of staples. A first sensor3808 is coupled to the anvil 3802 at a distal tip. The first sensor 3808is configured to detect one or more parameters of the end effector, suchas, for example, the distance, or gap 3814, between the anvil 3802 andthe staple cartridge 3806. The first sensor 3808 may comprise anysuitable sensor, such as, for example, a magnetic sensor. A magnet 3810may be coupled to the jaw member 3804 and/or the staple cartridge 3806to provide a magnetic signal to the magnetic sensor.

In some aspects, the end effector 3800 comprises a second sensor 3812.The second sensor 3812 is configured to detect one or more parameters ofthe end effector 3800 and/or a tissue section located therebetween. Thesecond sensor 3812 may comprise any suitable sensor, such as, forexample, one or more pressure sensors. The second sensor 3812 may becoupled to the anvil 3802, the jaw member 3804, and/or the staplecartridge 3806. A signal from the second sensor 3812 may be used toadjust the measurement of the first sensor 3808 to adjust the reading ofthe first sensor to accurately represent proximal and/or distalpositioned partial bites true compressed tissue thickness. In someaspects, the second sensor 3812 may be surrogate with respect to thefirst sensor 3808.

In some aspects, the second sensor 3812 may comprise, for example, asingle continuous pressure sensing film and/or an array of pressuresensing films. The second sensor 3812 is coupled to the deck of thestaple cartridge 3806 along the central axis covering, for example, aslot 3816 configured to receive a cutting and/or staple deploymentmember. The second sensor 3812 provides signals indicate of theamplitude of pressure applied by the tissue during a clamping procedure.During firing of the cutting and/or deployment member, the signal fromthe second sensor 3812 may be severed, for example, by cuttingelectrical connections between the second sensor 3812 and one or morecircuits. In some aspects, a severed circuit of the second sensor 3812may be indicative of a spent staple cartridge 3806. In other aspects,the second sensor 3812 may be positioned such that deployment of acutting and/or deployment member does not sever the connection to thesecond sensor 3812.

FIG. 70 illustrates one aspect of an end effector 3850 comprising asecond sensor 3862 located between a staple cartridge 3806 and a jawmember 3804. The end effector 3850 comprises a anvil, or anvil, 3852pivotally coupled to a jaw member 3854. The jaw member 3854 isconfigured to receive a staple cartridge 3856 therein. A first sensor3858 is coupled to the anvil 3852 at a distal tip. The first sensor 3858is configured to detect one or more parameters of the end effector 3850,such as, for example, the distance, or gap 3864, between the anvil 3852and the staple cartridge 3856. The first sensor 3858 may comprise anysuitable sensor, such as, for example, a magnetic sensor. A magnet 3860may be coupled to the jaw member 3854 and/or the staple cartridge 3856to provide a magnetic signal to the magnetic sensor. In some aspects,the end effector 3850 comprises a second sensor 3862 similar in allrespect to the second sensor 3812 of FIGS. 69A-69B, except that it islocated between the staple cartridge 3856 and the jaw member 3854.

FIG. 71 is a logic diagram illustrating one aspect of a process 3870 fordetermining and displaying the thickness of a tissue section clamped inan end effector 3800 or 3850, according to FIGS. 69A-69B or FIG. 70. Theprocess comprises obtaining a Hall effect voltage 3872, for example,through a Hall effect sensor located at the distal tip of the anvil3802. The Hall effect voltage 3872 is proved to an analog to digitalconverter 3876 and converted into a digital signal. The digital signalis provided to a process, such as for example the primary processor2006. The primary processor 2006 calibrates 3874 the curve input of theHall effect voltage 3872 signal. Pressure sensors, such as for example,second sensor 3812, is configured to measure 3880 one or more parametersof, for example, the end effector 3800, such as for example the amountof pressure being exerted by the anvil 3802 on the tissue clamped in theend effector 3800. In some aspects the pressure sensors may comprise asingle continuous pressure sensing film and/or array of pressure sensingfilms. The pressure sensors may thus be operable determine variations inthe measure pressure at different locations between the proximal anddistal ends of the end effector 3800. The measured pressure is providedto the processor, such as for example the primary processor 2006. Theprimary processor 2006 uses one or more algorithms and/or lookup tablesto adjust 3882 the Hall effect voltage 3872 in response to the pressuremeasured 3880 by the pressure sensors to more accurately reflect thethickness of the tissue clamped between, for example, the anvil 3802 andthe staple cartridge 3806. The adjusted thickness is displayed 3878 toan operator by, for example, a display 2026 embedded in the surgicalinstrument 10.

FIG. 72 illustrates one aspect of an end effector 3900 comprising aplurality of second sensors 3192 a-3192 b located between a staplecartridge 3906 and an elongated channel 3904. The end effector 3900comprises an anvil 3902 pivotally coupled to a jaw member or elongatedchannel 3904. The elongated channel 3904 is configured to receive astaple cartridge 3906 therein. The anvil 3902 further comprises a firstsensor 3908 located in the distal tip. The first sensor 3908 isconfigured to detect one or more parameters of the end effector 3900,such as, for example, the distance, or gap, between the anvil 3902 andthe staple cartridge 3906. The first sensor 3908 may comprise anysuitable sensor, such as, for example, a magnetic sensor. A magnet 3910may be coupled to the elongated channel 3904 and/or the staple cartridge3906 to provide a magnetic signal to the first sensor 3908. In someaspects, the end effector 3900 comprises a plurality of second sensors3912 a-3912 c located between the staple cartridge 3906 and theelongated channel 3904. The second sensors 3912 a-3912 c may compriseany suitable sensors, such as for instance piezo-resistive pressure filmstrips. In some aspects, the second sensors 3912 a-3912 c may beuniformly distributed between the distal and proximal ends of the endeffector 3900.

In some aspects, signals from the second sensors 3912 a-3912 c may beused to adjust the measurement of the first sensor 3908. For instance,the signals from the second sensors 3912 a-3912 c may be used to adjustthe reading of the first sensor 3908 to accurately represent the gapbetween the anvil 3902 and the staple cartridge 3906, which may varybetween the distal and proximal ends of the end effector 3900, dependingon the location and/or density of tissue 3920 between the anvil 3902 andthe staple cartridge 3906. FIG. 11 illustrates an example of a partialbite of tissue 3920. As illustrated for purposes of this example, thetissue is located only in the proximal area of the end effector 3900,creating a high pressure 3918 area near the proximal area of the endeffector 3900 and a corresponding low pressure 3916 area near the distalend of the end effector.

FIGS. 73A and 73B further illustrate the effect of a full versus partialbite of tissue 3920. FIG. 73A illustrates the end effector 3900 with afull bite of tissue 3920, where the tissue 3920 is of uniform density.With a full bite of tissue 3920 of uniform density, the measured firstgap 3914 a at the distal tip of the end effector 3900 may beapproximately the same as the measured second gap 3922 a in the middleor proximal end of the end effector 3900. For example, the first gap3914 a may measure 2.4 mm, and the second gap may measure 2.3 mm. FIG.73B illustrates an end effector 3900 with a partial bite of tissue 3920,or alternatively a full bit of tissue 3920 of non-uniform density. Inthis case, the first gap 3914 b will measure less than the second gap3922 b measured at the thickest or densest portion of the tissue 3920.For example, the first gap may measure 1.0 mm, while the second gap maymeasure 1.9 mm. In the conditions illustrated in FIGS. 73A-73B, signalsfrom the second sensors 3912 a-3912 c, such as for instance measuredpressure at different points along the length of the end effector 3900,may be employed by the instrument to determine tissue 3920 placementand/or material properties of the tissue 3920. The instrument mayfurther be operable to use measured pressure over time to recognizetissue characteristics and tissue position, and dynamically adjusttissue thickness measurements.

FIG. 74 illustrates an aspect of an end effector 4050 that is configuredto determine the location of a cutting member or knife 4062. The endeffector 4050 comprises an anvil 4052 pivotally coupled to a jaw memberor elongated channel 4054. The elongated channel 4054 is configured toreceive a staple cartridge 4056 therein. The staple cartridge 4056further comprises a slot (not shown) and a cutting member or knife 4062located therein. The knife 4062 is operably coupled to a knife bar 4064.The knife bar 4064 is operable to move the knife 4062 from the proximalend of the slot to the distal end. The end effector 4050 may furthercomprise an optical sensor 4060 located near the proximal end of theslot. The optical sensor may be coupled to a processor, such as forinstance the primary processor 2006. The optical sensor 4060 may beoperable to emit an optical signal towards the knife bar 4064. The knifebar 4064 may further comprise a code strip 4066 along its length. Thecode strip 4066 may comprise cut-outs, notches, reflective pieces, orany other configuration that is optically readable. The code strip 4066is placed such that the optical signal from the optical sensor 4060 willreflect off or through the code strip 4066. As the knife 4062 moves andknife bar 4064 moves 4068 along the slot 4058, the optical sensor 4060will detect the reflection of the emitted optical signal coupled to thecode strip 4066. The optical sensor 4060 may be operable to communicatethe detected signal to the primary processor 2006. The primary processor2006 may be configured to use the detected signal to determine theposition of the knife 4062. The position of the knife 4062 may be sensedmore precisely by designing the code strip 4066 such that the detectedoptical signal has a gradual rise and fall.

FIG. 75 illustrates an example of the code strip 4066 in operation withred LEDs 4070 and infrared LEDs 4072. For purposes of this example only,the code strip 4066 comprises cut-outs. As the code strip 4066 moves4068, the light emitted by the red LEDs 4070 will be interrupted as thecut-outs passed before it. The infrared LEDs 4072 will therefore detectthe motion of the code strip 4066, and therefore, by extension, themotion of the knife 4062.

FIG. 76 depicts a partial view of the end effector 300 of the surgicalinstrument 10. In the example form depicted in FIG. 76, the end effector300 comprises a staple cartridge 1100 which is similar in many respectsto the surgical staple cartridge 304 (FIG. 15). Several parts of the endeffector 300 are omitted to enable a clearer understanding of thepresent disclosure. In certain instances, the end effector 300 mayinclude a first jaw such as, for example, the anvil 306 (FIG. 20) and asecond jaw such as, for example, the elongated channel 198 (FIG. 14). Incertain instances, as described above, the elongated channel 198 mayaccommodate a staple cartridge such as, for example, the surgical staplecartridge 304 or the staple cartridge 1100, for example. At least one ofthe elongated channel 198 and the anvil 306 may be movable relative tothe other one of the elongated channel 198 and the anvil 306 to capturetissue between the staple cartridge 1100 and the anvil 306. Variousactuation assemblies are described herein to facilitation motion of theelongated channel 198 and/or the anvil 306 between an open configuration(FIG. 1) and a closed configuration (FIG. 77), for example.

In certain instances, as described above, the E-beam 178 can be advanceddistally to deploy the staples 191 into the captured tissue and/oradvance the cutting edge 182 between a plurality of positions to engageand cut the captured tissue. As illustrated in FIG. 76, the cutting edge182 can be advanced distally along a path defined by the slot 193, forexample. In certain instances, the cutting edge 182 can be advanced froma proximal portion 1103 of the staple cartridge 1100 to a distal portion1105 of the staple cartridge 1100 to cut the captured tissue. In certaininstances, the cutting edge 182 can be retracted proximally from thedistal portion 1105 to the proximal portion 1103 by retraction of theE-beam 178 proximally, for example.

In certain instances, the cutting edge 182 can be employed to cut tissuecaptured by the end effector 300 in multiple procedures. The reader willappreciate that repetitive use of the cutting edge 182 may affect thesharpness of the cutting edge 182. The reader will also appreciate thatas the sharpness of the cutting edge 182 decreases, the force requiredto cut the captured tissue with the cutting edge 182 may increase.Referring to FIGS. 78-83, in certain instances, the surgical instrument10 may comprise a circuit 1106 (FIG. 78) for monitoring the sharpness ofthe cutting edge 182 during, before, and/or after operation of thesurgical instrument 10 in a surgical procedure, for example. In certaininstances, the circuit 1106 can be employed to test the sharpness of thecutting edge 182 prior to utilizing the cutting edge 182 to cut thecaptured tissue. In certain instances, the circuit 1106 can be employedto test the sharpness of the cutting edge 182 after the cutting edge 182has been used to cut the captured tissue. In certain instances, thecircuit 1106 can be employed to test the sharpness of the cutting edge182 prior to and after the cutting edge 182 is used to cut the capturedtissue. In certain instances, the circuit 1106 can be employed to testthe sharpness of the cutting edge 182 at the proximal portion 1103and/or at the distal portion 1105.

Referring to FIGS. 78-83, the circuit 1106 may include one or moresensors such as, for example, an optical sensor 1108; the optical sensor1108 of the circuit 1106 can be employed to test the reflective abilityof the cutting edge 182, for example. In certain instances, the abilityof the cutting edge 182 to reflect light may correlate with thesharpness of the cutting edge 182. In other words, a decrease in thesharpness of the cutting edge 182 may result in a decrease in theability of the cutting edge 182 to reflect the light. Accordingly, incertain instances, the dullness of the cutting edge 182 can be evaluatedby monitoring the intensity of the light reflected from the cutting edge182, for example. In certain instances, the optical sensor 1108 maydefine a light sensing region. The optical sensor 1108 can be orientedsuch that the optical sensing region is disposed in the path of thecutting edge 182, for example. The optical sensor 1108 may be employedto sense the light reflected from the cutting edge 182 while the cuttingedge 182 is in the optical sensing region, for example. A decrease inintensity of the reflected light beyond a threshold can indicate thatthe sharpness of the cutting edge 182 has decreased beyond an acceptablelevel.

Referring again to FIGS. 78-83, the circuit 1106 may include one or morelights sources such as, for example, a light source 1110. In certaininstances, the circuit 1106 may include a controller 1112(“microcontroller”) which may be operably coupled to the optical sensor1108, as illustrated in FIGS. 78-83. In certain instances, thecontroller 1112 may include a processor 1114 (“microprocessor”) and oneor more computer readable mediums or memory 1116 (“memory units”). Incertain instances, the memory 1116 may store various programinstructions, which when executed may cause the processor 1114 toperform a plurality of functions and/or calculations described herein.In certain instances, the memory 1116 may be coupled to the processor1114, for example. A power source 1118 can be configured to supply powerto the controller 1112, the optical sensors 1108, and/or the lightsources 1110, for example. In certain instances, the power source 1118may comprise a battery (or “battery pack” or “power pack”), such as a Liion battery, for example. In certain instances, the battery pack may beconfigured to be releasably mounted to the handle assembly 14 forsupplying power to the surgical instrument 10. A number of battery cellsconnected in series may be used as the power source 4428. In certaininstances, the power source 1118 may be replaceable and/or rechargeable,for example.

The controller 1112 and/or other controllers of the present disclosuremay be implemented using integrated and/or discrete hardware elements,software elements, and/or a combination of both. Examples of integratedhardware elements may include processors, microprocessors, controllers,integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers,semiconductor devices, chips, microchips, chip sets, controllers, SoC,and/or SIP. Examples of discrete hardware elements may include circuitsand/or circuit elements such as logic gates, field effect transistors,bipolar transistors, resistors, capacitors, inductors, and/or relays. Incertain instances, the controller 1112 may include a hybrid circuitcomprising discrete and integrated circuit elements or components on oneor more substrates, for example. In certain instances, the controller1112 and/or other controllers of the present disclosure may be a singlecore or multicore controller LM4F230H5QR as described in connection withFIGS. 14-17B.

In certain instances, the light source 1110 can be employed to emitlight which can be directed at the cutting edge 182 in the opticalsensing region, for example. The optical sensor 1108 may be employed tomeasure the intensity of the light reflected from the cutting edge 182while in the optical sensing region in response to exposure to the lightemitted by the light source 1110. In certain instances, the processor1114 may receive one or more values of the measured intensity of thereflected light and may store the one or more values of the measuredintensity of the reflected light on the memory 1116, for example. Thestored values can be detected and/or recorded before, after, and/orduring a plurality of surgical procedures performed by the surgicalinstrument 10, for example.

In certain instances, the processor 1114 may compare the measuredintensity of the reflected light to a predefined threshold values thatmay be stored on the memory 1116, for example. In certain instances, thecontroller 1112 may conclude that the sharpness of the cutting edge 182has dropped below an acceptable level if the measured light intensityexceeds the predefined threshold value by 1%, 5%, 10%, 25%, 50%, 100%and/or more than 100%, for example. In certain instances, the processor1114 can be employed to detect a decreasing trend in the stored valuesof the measured intensity of the light reflected from the cutting edge182 while in the optical sensing region.

In certain instances, the surgical instrument 10 may include one or morefeedback systems such as, for example, the feedback system 1120. Incertain instances, the processor 1114 can employ the feedback system1120 to alert a user if the measured light intensity of the lightreflected from cutting edge 182 while in the optical sensing region isbeyond the stored threshold value, for example. In certain instances,the feedback system 1120 may comprise one or more visual feedbacksystems such as display screens, backlights, and/or LEDs, for example.In certain instances, the feedback system 1120 may comprise one or moreaudio feedback systems such as speakers and/or buzzers, for example. Incertain instances, the feedback system 1120 may comprise one or morehaptic feedback systems, for example. In certain instances, the feedbacksystem 1120 may comprise combinations of visual, audio, and/or tactilefeedback systems, for example.

In certain instances, the surgical instrument 10 may comprise a firinglockout mechanism 1122 which can be employed to prevent advancement ofthe cutting edge 182. Various suitable firing lockout mechanisms aredescribed in greater detail in U.S. Patent Application Publication No.2014/0001231, entitled FIRING SYSTEM LOCKOUT ARRANGEMENTS FOR SURGICALINSTRUMENTS, which is herein incorporated by reference in its entirety.In certain instances, as illustrated in FIG. 78, the processor 1114 canbe operably coupled to the firing lockout mechanism 1122; the processor1114 may employ the firing lockout mechanism 1122 to prevent advancementof the cutting edge 182 in the event it is determined that the measuredintensity of the light reflected from the cutting edge 182 is beyond thestored threshold, for example. In other words, the processor 1114 mayactivate the firing lockout mechanism 1122 if the cutting edge is notsufficiently sharp to cut the tissue captured by the end effector 300.

In certain instances, the optical sensor 1108 and the light source 1110can be housed at a distal portion of the interchangeable shaft assembly200. In certain instances, the sharpness of cutting edge 182 can beevaluated by the optical sensor 1108, as described above, prior totransitioning the cutting edge 182 into the end effector 300. The firingbar 172 (FIG. 14) may advance the cutting edge 182 through the opticalsensing region defined by the optical sensor 1108 while the cutting edge182 is in the interchangeable shaft assembly 200 and prior to enteringthe end effector 300, for example. In certain instances, the sharpnessof cutting edge 182 can be evaluated by the optical sensor 1108 afterretracting the cutting edge 182 proximally from the end effector 300.The firing bar 172 (FIG. 14) may retract the cutting edge 182 throughthe optical sensing region defined by the optical sensor 1108 afterretracting the cutting edge 182 from the end effector 300 into theinterchangeable shaft assembly 200, for example.

In certain instances, the optical sensor 1108 and the light source 1110can be housed at a proximal portion of the end effector 300 which can beproximal to the staple cartridge 1100, for example. The sharpness ofcutting edge 182 can be evaluated by the optical sensor 1108 aftertransitioning the cutting edge 182 into the end effector 300 but priorto engaging the staple cartridge 1100, for example. In certaininstances, the firing bar 172 (FIG. 14) may advance the cutting edge 182through the optical sensing region defined by the optical sensor 1108while the cutting edge 182 is in the end effector 300 but prior toengaging the staple cartridge 1100, for example.

In various instances, the sharpness of cutting edge 182 can be evaluatedby the optical sensor 1108 as the cutting edge 182 is advanced by thefiring bar 172 through the slot 193. As illustrated in FIGS. 78-83, theoptical sensor 1108 and the light source 1110 can be housed at theproximal portion 1103 of the staple cartridge 1100, for example; and thesharpness of cutting edge 182 can be evaluated by the optical sensor1108 at the proximal portion 1103, for example. The firing bar 172 (FIG.14) may advance the cutting edge 182 through the optical sensing regiondefined by the optical sensor 1108 at the proximal portion 1103 beforethe cutting edge 182 engages tissue captured between the staplecartridge 1100 and the anvil 306, for example. In certain instances, asillustrated in FIGS. 78-83, the optical sensor 1108 and the light source1110 can be housed at the distal portion 1105 of the staple cartridge1100, for example. The sharpness of cutting edge 182 can be evaluated bythe optical sensor 1108 at the distal portion 1105. In certaininstances, the firing bar 172 (FIG. 14) may advance the cutting edge 182through the optical sensing region defined by the optical sensor 1108 atthe distal portion 1105 after the cutting edge 182 has passed throughthe tissue captured between the staple cartridge 1100 and the anvil 306,for example.

Referring again to FIG. 76, the staple cartridge 1100 may comprise aplurality of optical sensors 1108 and a plurality of corresponding lightsources 1110, for example. In certain instances, a pair of the opticalsensor 1108 and the light source 1110 can be housed at the proximalportion 1103 of the staple cartridge 1100, for example; and a pair ofthe optical sensor 1108 and the light source 1110 can be housed at thedistal portion 1105 of the staple cartridge 1100, for example. In suchinstances, the sharpness of the cutting edge 182 can be evaluated afirst time at the proximal portion 1103 prior to engaging the tissue,for example, and a second time at the distal portion 1105 after passingthrough the captured tissue, for example. The reader will appreciatethat an optical sensor 1108 may evaluate the sharpness of the cuttingedge 182 a plurality of times during a surgical procedure. For example,the sharpness of the cutting edge can be evaluated a first time duringadvancement of the cutting edge 182 through the slot 193 in a firingstroke, and a second time during retraction of the cutting edge 182through the slot 193 in a return stroke, for example. In other words,the light reflected from the cutting edge 182 can be measured by theoptical sensor 1108 once as the cutting edge is advanced through theoptical sensing region, and once as the cutting edge 182 is retractedthrough the optical sensing region, for example.

The reader will appreciate that the processor 1114 may receive aplurality of readings of the intensity of the light reflected from thecutting edge 182 from one or more of the optical sensors 1108. Incertain instances, the processor 1114 may be configured to discardoutliers and calculate an average reading from the plurality ofreadings, for example. In certain instances, the average reading can becompared to a threshold stored in the memory 1116, for example. Incertain instances, the processor 1114 may be configured to alert a userthrough the feedback system 1120 and/or activate the firing lockoutmechanism 1122 if it is determined that the calculated average readingis beyond the threshold stored in the memory 1116, for example.

In certain instances, as illustrated in FIGS. 77, 79, and 80, a pair ofthe optical sensor 1108 and the light source 1110 can be positioned onopposite sides of the staple cartridge 1100. In other words, the opticalsensor 1108 can be positioned on a first side 1124 of the slot 193, forexample, and the light source 1110 can be positioned on a second side1126, opposite the first side 1124, of the slot 193, for example. Incertain instances, the pair of the optical sensor 1108 and the lightsource 1110 can be substantially disposed in a plane transecting thestaple cartridge 1100, as illustrated in FIG. 77. The pair of theoptical sensor 1108 and the light source 1110 can be oriented to definean optical sensing region that is positioned, or at least substantiallypositioned, on the plane transecting the staple cartridge 1100, forexample. Alternatively, the pair of the optical sensor 1108 and thelight source 1110 can be oriented to define an optical sensing regionthat is positioned proximal to the plane transecting the staplecartridge 1100, for example, as illustrated in FIG. 80.

In certain instances, a pair of the optical sensor 1108 and the lightsource 1110 can be positioned on a same side of the staple cartridge1100. In other words, as illustrated in FIG. 81, the pair of the opticalsensor 1108 and the light source 1110 can be positioned on a first sideof the cutting edge 182, e.g. the side 1128, as the cutting edge 182 isadvanced through the slot 193. In such instances, the light source 1110can be oriented to direct light at the side 1128 of the cutting edge182; and the intensity of the light reflected from the side 1128, asmeasured by the optical sensor 1108, may represent the sharpness of theside 1128.

In certain instances, as illustrated in FIG. 82, a second pair of theoptical sensor 1108 and the light source 1110 can be positioned on asecond side of the cutting edge 182, e.g. the side 1130, for example.The second pair can be employed to evaluate the sharpness of the side1130. For example, the light source 1110 of the second pair can beoriented to direct light at the side 1130 of the cutting edge 182; andthe intensity of the light reflected from the side 1130, as measured bythe optical sensor 1108 of the second pair, may represent the sharpnessof the side 1130. In certain instances, the processor can be configuredto assess the sharpness of the cutting edge 182 based upon the measuredintensities of the light reflected from the sides 1128 and 1130 of thecutting edge 182, for example.

In certain instances, as illustrated in FIG. 77, a pair of the opticalsensor 1108 and the light source 1110 can be housed at the distalportion 1105 of the staple cartridge 1100. As illustrated in FIG. 81,the optical sensor 1108 can be positioned, or at least substantiallypositioned, on an axis LL which extends longitudinally along the path ofthe cutting edge 182 through the slot 193, for example. In addition, thelight source 1110 can be positioned distal to the cutting edge 182 andoriented to direct light at the cutting edge 182 as the cutting edge isadvanced toward the light source 1110, for example. Furthermore, theoptical sensor 1108 can be positioned, or at least substantiallypositioned, along an axis AA that intersects the axis LL, as illustratedin FIG. 81. In certain instances, the axis AA may be perpendicular tothe axis LL, for example. In any event, the optical sensor 1108 can beoriented to define an optical sensing region at the intersection of theaxis LL and the axis AA, for example.

The reader will appreciate that the position, orientation and/or numberof optical sensors and corresponding light sources described herein inconnection with the surgical instrument 10 are example aspects intendedfor illustration purposes. Various other arrangements of optical sensorsand light sources can be employed by the present disclosure to evaluatethe sharpness of the cutting edge 182.

The reader will appreciate that advancement of the cutting edge 182through the tissue captured by the end effector 300 may cause thecutting edge to collect tissue debris and/or bodily fluids during eachfiring of the surgical instrument 10. Such debris may interfere with theability of the circuit 1106 to accurately evaluate the sharpness of thecutting edge 182. In certain instances, the surgical instrument 10 canbe equipped with one or more cleaning mechanisms which can be employedto clean the cutting edge 182 prior to evaluating the sharpness of thecutting edge 182, for example.

Referring to FIG. 76, in certain instances, the staple cartridge 1100may include a first pair of the optical sensor 1108 and the light source1110, which can be housed in the proximal portion 1103 of the staplecartridge 1100, for example. Furthermore, as illustrated in FIG. 76, thestaple cartridge 1100 may include a first pair of the cleaning members1132, which can be housed in the proximal portion 1103 on opposite sidesof the slot 193. The first pair of the cleaning members 1132 can bepositioned distal to the first pair of the optical sensor 1108 and thelight source 1110, for example. As illustrated in FIG. 76, the staplecartridge 1100 may include a second pair of the optical sensor 1108 andthe light source 1110, which can be housed in the distal portion 1105 ofthe staple cartridge 1100, for example. As illustrated in FIG. 76, thestaple cartridge 1100 may include a second pair of the cleaning members1132, which can be housed in the distal portion 1105 on opposite sidesof the slot 193. The second pair of the cleaning members 1132 can bepositioned proximal to the second pair of the optical sensor 1108 andthe light source 1110.

Further to the above, as illustrated in FIG. 76, the cutting edge 182may be advanced distally in a firing stroke to cut tissue captured bythe end effector 300. As the cutting edge is advanced, a firstevaluation of the sharpness of the cutting edge 182 can be performed bythe first pair of the optical sensor 1108 and the light source 1110prior to tissue engagement by the cutting edge 182, for example. Asecond evaluation of the sharpness of the cutting edge 182 can beperformed by the second pair of the optical sensor 1108 and the lightsource 1110 after the cutting edge 182 has transected the capturedtissue, for example. The cutting edge 182 may be advanced through thesecond pair of the cleaning members 1132 prior to the second evaluationof the sharpness of the cutting edge 182 to remove any debris collectedby the cutting edge 182 during the transection of the captured tissue.

Further to the above, as illustrated in FIG. 76, the cutting edge 182may be retracted proximally in a return stroke. As the cutting edge isretracted, a third evaluation of the sharpness of the cutting edge 182can be performed by the first pair of the optical sensor 1108 and thelight source 1110 during the return stroke. The cutting edge 182 may beretracted through the first pair of the cleaning members 1132 prior tothe third evaluation of the sharpness of the cutting edge 182 to removeany debris collected by the cutting edge 182 during the transection ofthe captured tissue, for example.

In certain instances, one or more of the lights sources 1110 maycomprise one or more optical fiber cables. In certain instances, one ormore flex circuits 1134 can be employed to transmit energy from thepower source 1118 to the optical sensors 1108 and/or the light sources1110. In certain instances, the flex circuits 1134 may be configured totransmit one or more of the readings of the optical sensors 1108 to thecontroller 1112, for example.

Referring now to FIG. 84, a staple cartridge 4300 is depicted; thestaple cartridge 4300 is similar in many respects to the surgical staplecartridge 304 (FIG. 14). For example, the staple cartridge 4300 can beemployed with the end effector 300. In certain instances, as illustratedin FIG. 84, the staple cartridge 4300 may comprise a sharpness testingmember 4302 which can be employed to test the sharpness of the cuttingedge 182. In certain instances, the sharpness testing member 4302 can beattached to and/or integrated with the cartridge body 194 of the staplecartridge 4300, for example. In certain instances, the sharpness testingmember 4302 can be disposed in the proximal portion 1103 of the staplecartridge 4300, for example. In certain instances, as illustrated inFIG. 84, the sharpness testing member 4302 can be disposed onto acartridge deck 4304 of the staple cartridge 4300, for example.

In certain instances, as illustrated in FIG. 84, the sharpness testingmember 4302 can extend across the slot 193 of the staple cartridge 4300to bridge, or at least partially bridge, the gap defined by the slot193, for example. In certain instances, the sharpness testing member4302 may interrupt, or at least partially interrupt, the path of thecutting edge 182. The cutting edge 182 may engage, cut, and/or passthrough the sharpness testing member 4302 as the cutting edge 182 isadvanced during a firing stroke, for example. In certain instances, thecutting edge 182 may be configured to engage, cut, and/or pass throughthe sharpness testing member 4302 prior to engaging tissue captured bythe end effector 300 in a firing stroke, for example. In certaininstances, the cutting edge 182 may be configured to engage thesharpness testing member 4302 at a proximal end 4306 of the sharpnesstesting member 4302, and exit and/or disengage the sharpness testingmember 4302 at a distal end 4308 of the sharpness testing member 4302,for example. In certain instances, the cutting edge 182 can traveland/or cut through the sharpness testing member 4302 a distance (D)between the proximal end 4306 and the distal end 4308, for example, asthe cutting edge 182 is advanced during a firing stroke.

Referring primarily to FIGS. 84 and 85, the surgical instrument 10 maycomprise a circuit 4310 for testing the sharpness of the cutting edge182, for example. In certain instances, the circuit 4310 can evaluatethe sharpness of the cutting edge 182 by testing the ability of thecutting edge 182 to be advanced through the sharpness testing member4302. For example, the circuit 4310 can be configured to observe thetime period the cutting edge 182 takes to fully transect and/orcompletely pass through at least a predetermined portion of thesharpness testing member 4302. If the observed time period exceeds apredetermined threshold, the circuit 4310 may conclude that thesharpness of the cutting edge 182 has dropped below an acceptable level,for example.

In certain instances, the circuit 4310 may include a controller 4312(“microcontroller”) which may include a processor 4314(“microprocessor”) and one or more computer readable mediums or memory4316 units (“memory”). In certain instances, the memory 4316 may storevarious program instructions, which when executed may cause theprocessor 4314 to perform a plurality of functions and/or calculationsdescribed herein. In certain instances, the memory 4316 may be coupledto the processor 4314, for example. A power source 4318 can beconfigured to supply power to the controller 4312, for example. Incertain instances, the power source 4138 may comprise a battery (or“battery pack” or “power pack”), such as a Li ion battery, for example.In certain instances, the battery pack may be configured to bereleasably mounted to the handle assembly 14. A number of battery cellsconnected in series may be used as the power source 4318. In certaininstances, the power source 4318 may be replaceable and/or rechargeable,for example.

In certain instances, the controller 4313 can be operably coupled to thefeedback system 1120 and/or the firing lockout mechanism 1122, forexample.

Referring to FIGS. 84 and 85, the circuit 4310 may comprise one or moreposition sensors. Example position sensors and positioning systemssuitable for use with the present disclosure are described in U.S.Patent Application Publication No. 2014/0263538, entitled SENSORARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS,now U.S. Pat. No. 9,808,244, which is herein incorporated by referencein its entirety. In certain instances, the circuit 4310 may include afirst position sensor 4320 and a second position sensor 4322. In certaininstances, the first position sensor 4320 can be employed to detect afirst position of the cutting edge 182 at the proximal end 4306 of thesharpness testing member 4302, for example; and the second positionsensor 4322 can be employed to detect a second position of the cuttingedge 182 at the distal end 4308 of the sharpness testing member 4302,for example.

In certain instances, the first and second position sensors 4320, 4322can be employed to provide first and second position signals,respectively, to the controller 4312. It will be appreciated that theposition signals may be analog signals or digital values based on theinterface between the controller 4312 and the first and second positionsensors 4320, 4322. In one aspect, the interface between the controller4312 and the first and second position sensors 4320, 4322 can be astandard serial peripheral interface (SPI), and the position signals canbe digital values representing the first and second positions of thecutting edge 182, as described above.

Further to the above, the processor 4314 may determine the time periodbetween receiving the first position signal and receiving the secondposition signal. The determined time period may correspond to the timeit takes the cutting edge 182 to advance through the sharpness testingmember 4302 from the first position at the proximal end 4306 of thesharpness testing member 4302, for example, to the second position atthe distal end 4308 of the sharpness testing member 4302, for example.In at least one example, the controller 4312 may include a time elementwhich can be activated by the processor 4314 upon receipt of the firstposition signal, and deactivated upon receipt of the second positionsignal. The time period between the activation and deactivation of thetime element may correspond to the time it takes the cutting edge 182 toadvance from the first position to the second position, for example. Thetime element may comprise a real time clock, a processor configured toimplement a time function, or any other suitable timing circuit.

In various instances, the controller 4312 can compare the time period ittakes the cutting edge 182 to advance from the first position to thesecond position to a predefined threshold value to assess whether thesharpness of the cutting edge 182 has dropped below an acceptable level,for example. In certain instances, the controller 4312 may conclude thatthe sharpness of the cutting edge 182 has dropped below an acceptablelevel if the measured time period exceeds the predefined threshold valueby 1%, 5%, 10%, 25%, 50%, 100% and/or more than 100%, for example.

Referring to FIG. 86, in various instances, an electric motor 4330 candrive the firing bar 172 (FIG. 14) to advance the cutting edge 182during a firing stroke and/or to retract the cutting edge 182 during areturn stroke, for example. A motor driver 4332 can control the electricmotor 4330; and a controller such as, for example, the controller 4312can be in signal communication with the motor driver 4332. As theelectric motor 4330 advances the cutting edge 182, the controller 4312can determine the current drawn by the electric motor 4330, for example.In such instances, the force required to advance the cutting edge 182can correspond to the current drawn by the electric motor 4330, forexample. Referring still to FIG. 86, the controller 4312 of the surgicalinstrument 10 can determine if the current drawn by the electric motor4330 increases during advancement of the cutting edge 182 and, if so,can calculate the percentage increase of the current.

In certain instances, the current drawn by the electric motor 4330 mayincrease significantly while the cutting edge 182 is in contact with thesharpness testing member 4302 due to the resistance of the sharpnesstesting member 4302 to the cutting edge 182. For example, the currentdrawn by the electric motor 4330 may increase significantly as thecutting edge 182 engages, passes and/or cuts through the sharpnesstesting member 4302. The reader will appreciate that the resistance ofthe sharpness testing member 4302 to the cutting edge 182 depends, inpart, on the sharpness of the cutting edge 182; and as the sharpness ofthe cutting edge 182 decreases from repetitive use, the resistance ofthe sharpness testing member 4302 to the cutting edge 182 will increase.Accordingly, the value of the percentage increase of the current drawnby the electric motor 4330 while the cutting edge is in contact with thesharpness testing member 4302 can increase as the sharpness of thecutting edge 182 decreases from repetitive use, for example.

In certain instances, the determined value of the percentage increase ofthe current drawn by the electric motor 4330 can be the maximum detectedpercentage increase of the current drawn by the electric motor 4330. Invarious instances, the controller 4312 can compare the determined valueof the percentage increase of the current drawn by the electric motor4330 to a predefined threshold value of the percentage increase of thecurrent drawn by the electric motor 4330. If the determined valueexceeds the predefined threshold value, the controller 4312 may concludethat the sharpness of the cutting edge 182 has dropped below anacceptable level, for example.

In certain instances, as illustrated in FIG. 86, the processor 4314 canbe in communication with the feedback system 1120 and/or the firinglockout mechanism 1122, for example. In certain instances, the processor4314 can employ the feedback system 1120 to alert a user if thedetermined value of the percentage increase of the current drawn by theelectric motor 4330 exceeds the predefined threshold value, for example.In certain instances, the processor 4314 may employ the firing lockoutmechanism 1122 to prevent advancement of the cutting edge 182 if thedetermined value of the percentage increase of the current drawn by theelectric motor 4330 exceeds the predefined threshold value, for example.

In various instances, the controller 4312 can utilize an algorithm todetermine the change in current drawn by the electric motor 4330. Forexample, a current sensor can detect the current drawn by the electricmotor 4330 during the firing stroke. The current sensor can continuallydetect the current drawn by the electric motor and/or can intermittentlydetect the current draw by the electric motor. In various instances, thealgorithm can compare the most recent current reading to the immediatelyproceeding current reading, for example. Additionally or alternatively,the algorithm can compare a sample reading within a time period X to aprevious current reading. For example, the algorithm can compare thesample reading to a previous sample reading within a previous timeperiod X, such as the immediately proceeding time period X, for example.In other instances, the algorithm can calculate the trending average ofcurrent drawn by the motor. The algorithm can calculate the averagecurrent draw during a time period X that includes the most recentcurrent reading, for example, and can compare that average current drawto the average current draw during an immediately proceeding time periodtime X, for example.

Referring to FIG. 87, a method 4500 is depicted for evaluating thesharpness of the cutting edge 182 of the surgical instrument 10; andvarious responses are outlined in the event the sharpness of the cuttingedge 182 drops to and/or below an alert threshold and/or a high severitythreshold, for example. In various instances, a controller such as, forexample, the controller 4312 can be configured to implement the methoddepicted in FIG. 85. In certain instances, the surgical instrument 10may include a load cell 4334 (FIG. 86); as illustrated in FIG. 84, thecontroller 4312 may be in communication with the load cell 4334. Incertain instances, the load cell 4334 may include a force sensor suchas, for example, a strain gauge, which can be operably coupled to thefiring bar 172, for example. In certain instances, the controller 4312may employ the load cell 4334 to monitor the force (Fx) applied to thecutting edge 182 as the cutting edge 182 is advanced during a firingstroke.

Accordingly, when the knife firing is initiated 4502 the system checks4504 the dullness of the cutting edge 182 of the knife by sensing aforce Fx. The sensed force Fx is compared to a threshold force F1 anddetermines 4506 whether the sensed force Fx is greater than thethreshold force F1. When the sensed force Fx is less than or equal tothe threshold force F1, the process proceeds along NO branch anddisplays 4508 nothing and continues 4510 the knife firing process. Whenthe sensed force Fx is greater than the threshold force F1, the processproceeds along YES branch and determines 4512 whether the sensed forceFx exceeds a high severity threshold force F2. When the sensed force Fxis less than or equal to the threshold F2, the process proceeds along NObranch and notifies 4514 the processor that the cutting edge 182 of theknife is dulling and the continues 4510 the knife firing process. Whenthe sensed force Fx is greater than the threshold F2, the processproceeds along YES branch and notifies 4516 the processor that thecutting edge 182 of the knife is dulled and the knife firing lockout isengaged. Subsequently, optionally, the processor may override 4518 theknife firing lockout and continues 4510 the knife firing process if thelockout is overridden.

Referring to FIG. 88, a method 4600 is depicted for determining whethera cutting edge such as, for example, the cutting edge 182 issufficiently sharp to be employed in transecting a tissue of aparticular tissue thickness that is captured by the end effector 300,for example. As described above, repetitive use of the cutting edge 182may dull or reduce the sharpness of the cutting edge 182 which mayincrease the force required for the cutting edge 182 to transect thecaptured tissue. In other words, the sharpness level of the cutting edge182 can be defined by the force required for the cutting edge 182 totransect the captured tissue, for example. The reader will appreciatethat the force required for the cutting edge 182 to transect a capturedtissue may also depend on the thickness of the captured tissue. Incertain instances, the greater the thickness of the captured tissue, thegreater the force required for the cutting edge 182 to transect thecaptured tissue at the same sharpness level, for example.

Accordingly, initially, the stapler clamps 4602 the tissue between theanvil and the jaw member. The system senses 4604 the tissue thickness Txand initiates 4606 the knife firing process. Upon initiating the knifefiring process, the system senses 4608 the load resistance from theclamped tissue and compares the sensed force Fx and senses thickness Txagainst various thresholds and determines 4610 several outcomes based onthe evaluation. In one aspect, when the process determines 4610 whetherthe sensed tissue thickness Tx is within a first tissue thickness rangedefined between a first tissue thickness threshold T1 and a secondtissue thickness threshold T2 AND the sensed force Fx is greater than afirst force threshold F1 AND the process determines 4610 whether thesensed tissue thickness Tx is within a second tissue thickness rangedefined between the second tissue thickness threshold T2 and a thirdtissue thickness threshold T3 AND the sensed force Fx is greater than asecond force threshold F2, the process proceeds along the YES branch andnotifies 4612 or alerts the processor that the knife is dulling and thencontinues 4614 the knife firing process. Otherwise, the process proceedsalong the NO branch and the does not notify 4616 the processor andcontinues the knife firing process. Generally, the process determineswhether the sensed tissue thickness Tx is within a tissue thicknessrange defined between tissue thickness thresholds Tn and Tn+1 AND thesensed force Fx is greater than a force threshold Tn, where n indicatesa tissue thickness range. When the process determines 4610 that thesensed tissue thickness Tx is within a first tissue thickness rangedefined between a first tissue thickness threshold T1 and a secondtissue thickness threshold T2 AND the sensed force Fx is greater than afirst force threshold F1 AND when the process determines 4610 that thesensed tissue thickness Tx is within a second tissue thickness rangedefined between the second tissue thickness threshold T2 and a thirdtissue thickness threshold T3 AND the sensed force Fx is greater than asecond force threshold F2, the process continues.

In certain instances, the cutting edge 182 may be sufficiently sharp fortransecting a captured tissue comprising a first thickness but may notbe sufficiently sharp for transecting a captured tissue comprising asecond thickness greater than the first thickness, for example. Incertain instances, a sharpness level of the cutting edge 182, as definedby the force required for the cutting edge 182 to transect a capturedtissue, may be adequate for transecting the captured tissue if thecaptured tissue comprises a tissue thickness that is in a particularrange of tissue thicknesses, for example.

In certain instances, as illustrated in FIG. 89, the memory 4316 canstore one or more predefined ranges of tissue thicknesses of tissuecaptured by the end effector 300; and predefined threshold forcesassociated with the predefined ranges of tissue thicknesses. In certaininstances, each predefined threshold force may represent a minimumsharpness level of the cutting edge 182 that is suitable for transectinga captured tissue comprising a tissue thickness (Tx) encompassed by therange of tissue thicknesses that is associated with the predefinedthreshold force. In certain instances, if the force (Fx) required forthe cutting edge 182 to transect the captured tissue, comprising thetissue thickness (Tx), exceeds the predefined threshold force associatedwith the predefined range of tissue thicknesses that encompasses thetissue thickness (Tx), the cutting edge 182 may not be sufficientlysharp to transect the captured tissue, for example.

In certain instances, the predefined threshold forces and theircorresponding predefined ranges of tissue thicknesses can be stored in adatabase and/or a table on the memory 4316 such as, for example, a table4342, as illustrated in FIG. 89. In certain instances, the processor4314 can be configured to receive a measured value of the force (Fx)required for the cutting edge 182 to transect a captured tissue and ameasured value of the tissue thickness (Tx) of the captured tissue. Theprocessor 4314 may access the table 4342 to determine the predefinedrange of tissue thicknesses that encompasses the measured tissuethickness (Tx). In addition, the processor 4314 may compare the measuredforce (Fx) to the predefined threshold force associated with thepredefined range of tissue thicknesses that encompasses the tissuethickness (Tx). In certain instances, if the measured force (Fx) exceedsthe predefined threshold force, the processor 4314 may conclude that thecutting edge 182 may not be sufficiently sharp to transect the capturedtissue, for example.

Further to the above, the processor 4314 (FIGS. 85, 86) may employ oneor more tissue thickness sensing modules such as, for example, a tissuethickness sensing module 4336 to determine the thickness of the capturedtissue. Various suitable tissue thickness sensing modules are describedin the present disclosure. In addition, various tissue thickness sensingdevices and methods, which are suitable for use with the presentdisclosure, are disclosed in U.S. Patent Application Publication No.2011/0155781, entitled SURGICAL CUTTING INSTRUMENT THAT ANALYZES TISSUETHICKNESS, now U.S. Pat. No. 8,851,354, which is herein incorporated byreference in its entirety.

In certain instances, the processor 4314 may employ the load cell 4334to measure the force (Fx) required for the cutting edge 182 to transecta captured tissue comprising a tissue thickness (Tx). The reader willappreciate that that the force applied to the cutting edge 182 by thecaptured tissue, while the cutting edge 182 is engaged and/or in contactwith the captured tissue, may increase as the cutting edge 182 isadvanced against the captured tissue up to the force (Fx) at which thecutting edge 182 may transect the captured tissue. In certain instances,the processor 4314 may employ the load cell 4334 to continually monitorthe force applied by the captured tissue against the cutting edge 182 asthe cutting edge 182 is advanced against the captured tissue. Theprocessor 4314 may continually compare the monitored force to thepredefined threshold force associated with the predefined tissuethickness range encompassing the tissue thickness (Tx) of the capturedtissue. In certain instances, if the monitored force exceeds thepredefined threshold force, the processor 4314 may conclude that thecutting edge is not sufficiently sharp to safely transect the capturedtissue, for example.

The method 4600 described in FIG. 88 outline various example actionsthat can be taken by the controller 4313 in the event it is determinedthat the cutting edge 182 is not be sufficiently sharp to safelytransect the captured tissue, for example. In certain instances, thecontroller 4312 may warn the user that the cutting edge 182 is too dullfor safe use, for example, through the feedback system 1120, forexample. In certain instances, the controller 4312 may employ the firinglockout mechanism 1122 to prevent advancement of the cutting edge 182upon concluding that the cutting edge 182 is not sufficiently sharp tosafely transect the captured tissue, for example. In certain instances,the controller 4312 may employ the feedback system 1120 to provideinstructions to the user for overriding the firing lockout mechanism1122, for example.

FIGS. 90, 91 illustrate various aspects of an apparatus, system, andmethod for employing a common controller with a plurality of motors inconnection with a surgical instrument such as, for example, amotor-driven surgical instrument 4400. The surgical instrument 4400 issimilar in many respects to other surgical instruments described by thepresent disclosure such as, for example, the surgical instrument 10 ofFIG. 1 which is described in greater detail above. The surgicalinstrument 4400 includes the housing 12, the handle assembly 14, theclosure trigger 32, the interchangeable shaft assembly 200, and the endeffector 300. Accordingly, for conciseness and clarity of disclosure, adetailed description of certain features of the surgical instrument4400, which are common with the surgical instrument 10, will not berepeated here.

Referring still to FIGS. 90, 91, the surgical instrument 4400 mayinclude a plurality of motors which can be activated to perform variousfunctions in connection with the operation of the surgical instrument4400. In certain instances, a first motor can be activated to perform afirst function; a second motor can be activated to perform a secondfunction; and a third motor can be activated to perform a thirdfunction. In certain instances, the plurality of motors of the surgicalinstrument 4400 can be individually activated to cause articulation,closure, and/or firing motions in the end effector 300 (FIGS. 1, 15).The articulation, closure, and/or firing motions can be transmitted tothe end effector 300 through the interchangeable shaft assembly 200(FIG. 1), for example.

In certain instances, as illustrated in FIG. 91, the surgical instrument4400 may include a firing motor 4402. The firing motor 4402 may beoperably coupled to a firing drive assembly 4404 which can be configuredto transmit firing motions generated by the firing motor 4402 to the endeffector 300 (FIGS. 1, 14). In certain instances, the firing motionsgenerated by the firing motor 4402 may cause the staples 191 to bedeployed from the surgical staple cartridge 304 into tissue captured bythe end effector 300 and/or the cutting edge 182 to be advanced to cutthe captured tissue, for example.

In certain instances, as illustrated in FIG. 91, the surgical instrument4400 may include an articulation motor 4406, for example. Thearticulation motor 4406 may be operably coupled to an articulation driveassembly 4408 which can be configured to transmit articulation motionsgenerated by the articulation motor 4406 to the end effector 300 (FIGS.1, 14). In certain instances, the articulation motions may cause the endeffector 300 to articulate relative to the interchangeable shaftassembly 200 (FIG. 1), for example. In certain instances, the surgicalinstrument 4400 may include a closure motor, for example. The closuremotor may be operably coupled to a closure drive assembly which can beconfigured to transmit closure motions to the end effector 300. Incertain instances, the closure motions may cause the end effector 300 totransition from an open configuration to an approximated configurationto capture tissue, for example. The reader will appreciate that themotors described herein and their corresponding drive assemblies areintended as examples of the types of motors and/or driving assembliesthat can be employed in connection with the present disclosure. Thesurgical instrument 4400 may include various other motors which can beutilized to perform various other functions in connection with theoperation of the surgical instrument 4400.

As described above, the surgical instrument 4400 may include a pluralityof motors which may be configured to perform various independentfunctions. In certain instances, the plurality of motors of the surgicalinstrument 4400 can be individually or separately activated to performone or more functions while the other motors remain inactive. Forexample, the articulation motor 4406 can be activated to cause the endeffector 300 (FIGS. 1, 14) to be articulated while the firing motor 4402remains inactive. Alternatively, the firing motor 4402 can be activatedto fire the plurality of staples 191 (FIG. 14) and/or advance thecutting edge 182 while the articulation motor 4406 remains inactive.

With reference to FIGS. 90, 91, in certain instances, the surgicalinstrument 4400 may include a common controller 4410 which can beemployed with a plurality of motors 4402, 4406 of the surgicalinstrument 4400. In certain instances, the common controller 4410 mayaccommodate one of the plurality of motors at a time. For example, thecommon controller 4410 can be separably couplable to the plurality ofmotors of the surgical instrument 4400 individually. In certaininstances, a plurality of the motors of the surgical instrument 4400 mayshare one or more common controllers such as the common controller 4410.In certain instances, a plurality of motors of the surgical instrument4400 can be individually and selectively engaged the common controller4410. In certain instances, the common controller 4410 can beselectively switched from interfacing with one of a plurality of motorsof the surgical instrument 4400 to interfacing with another one of theplurality of motors of the surgical instrument 4400.

In at least one example, the common controller 4410 can be selectivelyswitched between operable engagement with the articulation motor 4406and operable engagement with the firing motor 4402. In at least oneexample, as illustrated in FIG. 90, a switch 4414 can be moved ortransitioned between a plurality of positions and/or states such as afirst position 4416 and a second position 4418, for example. In thefirst position 4416, the switch 4414 may electrically couple the commoncontroller 4410 to the articulation motor 4406; and in the secondposition 4418, the switch 4414 may electrically couple the commoncontroller 4410 to the firing motor 4402, for example. In certaininstances, the common controller 4410 can be electrically coupled to thearticulation motor 4406, while the switch 4414 is in the first position4416, to control the operation of the articulation motor 4406 toarticulate the end effector 300 (FIGS. 1, 15) to a desired position. Incertain instances, the common controller 4410 can be electricallycoupled to the firing motor 4402, while the switch 4414 is in the secondposition 4418, to control the operation of the firing motor 4402 to firethe plurality of staples 191 (FIG. 14) and/or advance the cutting edge182 (FIG. 14), for example. In certain instances, the switch 4414 may bea mechanical switch, an electromechanical switch, a solid state switch,or any suitable switching mechanism.

Referring now to FIG. 91, an outer casing of the handle assembly 14 ofthe surgical instrument 4400 is removed and several features andelements of the surgical instrument 4400 are also removed for clarity ofdisclosure. In certain instances, as illustrated in FIG. 91, thesurgical instrument 4400 may include an interface 4412 which can beselectively transitioned between a plurality of positions and/or states.In a first position and/or state, the interface 4412 may couple thecommon controller 4410 (FIG. 90) to a first motor such as, for example,the articulation motor 4406; and in a second position and/or state, theinterface 4412 may couple the common controller 4410 to a second motorsuch as, for example, the firing motor 4402. Additional positions and/orstates of the interface 4412 are contemplated by the present disclosure.

In certain instances, the interface 4412 is movable between a firstposition and a second position, wherein the common controller 4410 (FIG.90) is coupled to a first motor in the first position and a second motorin the second position. In certain instances, the common controller 4410is decoupled from first motor as the interface 4412 is moved from thefirst position; and the common controller 4410 is decoupled from secondmotor as the interface 4412 is moved from the second position. Incertain instances, a switch or a trigger can be configured to transitionthe interface 4412 between the plurality of positions and/or states. Incertain instances, a trigger can be movable to simultaneously effectuatethe end effector and transition the common controller 4410 from operableengagement with one of the motors of the surgical instrument 4400 tooperable engagement with another one of the motors of the surgicalinstrument 4400.

In at least one example, as illustrated in FIG. 91, the closure trigger32 can be operably coupled to the interface 4412 and can be configuredto transition the interface 4412 between a plurality of positions and/orstates. As illustrated in FIG. 91, the closure trigger 32 can bemovable, for example during a closure stroke, to transition theinterface 4412 from a first position and/or state to a second positionand/or state while transitioning the end effector 300 to an approximatedconfiguration to capture tissue by the end effector, for example.

In certain instances, in the first position and/or state, the commoncontroller 4410 can be electrically coupled to a first motor such as,for example, the articulation motor 4406, and in the second positionand/or state, the common controller 4410 can be electrically coupled toa second motor such as, for example, the firing motor 4402. In the firstposition and/or state, the common controller 4410 may be engaged withthe articulation motor 4406 to allow the user to articulate the endeffector 300 (FIGS. 1, 15) to a desired position; and the commoncontroller 4410 may remain engaged with the articulation motor 4406until the closure trigger 32 is actuated. As the user actuates theclosure trigger 32 to capture tissue by the end effector 300 at thedesired position, the interface 4412 can be transitioned or shifted totransition the common controller 4410 from operable engagement with thearticulation motor 4406, for example, to operable engagement with thefiring motor 4402, for example. Once operable engagement with the firingmotor 4402 is established, the common controller 4410 may take controlof the firing motor 4402; and the common controller 4410 may activatethe firing motor 4402, in response to user input, to fire the pluralityof staples 191 (FIG. 14) and/or advance the cutting edge 182 (FIG. 14),for example.

In certain instances, as illustrated in FIG. 91, the common controller4410 may include a plurality of electrical and/or mechanical contacts4411 adapted for coupling engagement with the interface 4412. Theplurality of motors of the surgical instrument 4400, which share thecommon controller 4410, may each comprise one or more correspondingelectrical and/or mechanical contacts 4413 adapted for couplingengagement with the interface 4412, for example.

In various instances, the motors of the surgical instrument 4400 can beelectrical motors. In certain instances, one or more of the motors ofthe surgical instrument 4400 can be a DC brushed driving motor having amaximum rotation of, approximately, 25,000 RPM, for example. In otherarrangements, the motors of the surgical instrument 4400 may include oneor more motors selected from a group of motors comprising a brushlessmotor, a cordless motor, a synchronous motor, a stepper motor, or anyother suitable electric motor.

In various instances, as illustrated in FIG. 90, the common controller4410 may comprise a motor driver 4426 which may comprise one or moreH-Bridge field-effect transistors (FETs). The motor driver 4426 maymodulate the power transmitted from a power source 4428 to a motorcoupled to the common controller 4410 based on input from a controller4420 (“microcontroller”), for example. In certain instances, thecontroller 4420 can be employed to determine the current drawn by themotor, for example, while the motor is coupled to the common controller4410, as described above.

In certain instances, the controller 4420 may include a processor 4422(“microprocessor”) and one or more computer readable mediums or memory4424 units (“memory”). In certain instances, the memory 4424 may storevarious program instructions, which when executed may cause theprocessor 4422 to perform a plurality of functions and/or calculationsdescribed herein. In certain instances, one or more of the memory 4424may be coupled to the processor 4422, for example.

In certain instances, the power source 4428 can be employed to supplypower to the controller 4420, for example. In certain instances, thepower source 4428 may comprise a battery (or “battery pack” or “powerpack”), such as a Li ion battery, for example. In certain instances, thebattery pack may be configured to be releasably mounted to the handleassembly 14 for supplying power to the surgical instrument 4400. Anumber of battery cells connected in series may be used as the powersource 4428. In certain instances, the power source 4428 may bereplaceable and/or rechargeable, for example.

In various instances, the processor 4422 may control the motor driver4426 to control the position, direction of rotation, and/or velocity ofa motor that is coupled to the common controller 4410. In certaininstances, the processor 4422 can signal the motor driver 4426 to stopand/or disable a motor that is coupled to the common controller 4410. Itshould be understood that the term processor as used herein includes anysuitable processor, controller, or other basic computing device thatincorporates the functions of a computer's central processing unit (CPU)on an integrated circuit or at most a few integrated circuits. Theprocessor is a multipurpose, programmable device that accepts digitaldata as input, processes it according to instructions stored in itsmemory, and provides results as output. It is an example of sequentialdigital logic, as it has internal memory. Processors operate on numbersand symbols represented in the binary numeral system. In one instance,the processor 4422 may be a single core or multicore controllerLM4F230H5QR as described in connection with FIGS. 15-17B.

In certain instances, the memory 4424 may include program instructionsfor controlling each of the motors of the surgical instrument 4400 thatare couplable to the common controller 4410. For example, the memory4424 may include program instructions for controlling the articulationmotor 4406. Such program instructions may cause the processor 4422 tocontrol the articulation motor 4406 to articulate the end effector 300in accordance with user input while the articulation motor 4406 iscoupled to the common controller 4410. In another example, the memory4424 may include program instructions for controlling the firing motor4402. Such program instructions may cause the processor 4422 to controlthe firing motor 4402 to fire the plurality of staples 191 and/oradvance the cutting edge 182 in accordance with user input while thefiring motor 4402 is coupled to the common controller 4410.

In certain instances, one or more mechanisms and/or sensors such as, forexample, sensors 4430 can be employed to alert the processor 4422 to theprogram instructions that should be used in a particular setting. Forexample, the sensors 4430 may alert the processor 4422 to use theprogram instructions associated with articulation of the end effector300 (FIGS. 1, 14) while the common controller 4410 is coupled to thearticulation motor 4406; and the sensors 4430 may alert the processor4422 to use the program instructions associated with firing the surgicalinstrument 4400 while the common controller 4410 is coupled to thefiring motor 4402. In certain instances, the sensors 4430 may compriseposition sensors which can be employed to sense the position of theswitch 4414, for example. Accordingly, the processor 4422 may use theprogram instructions associated with articulation of the end effector300 upon detecting, through the sensors 4430 for example, that theswitch 4414 is in the first position 4416; and the processor 4422 mayuse the program instructions associated with firing the surgicalinstrument 4400 upon detecting, through the sensors 4430 for example,that the switch 4414 is in the second position 4418.

Referring now to FIG. 92, an outer casing of the surgical instrument4400 is removed and several features and elements of the surgicalinstrument 4400 are also removed for clarity of disclosure. Asillustrated in FIG. 92, the surgical instrument 4400 may include aplurality of sensors which can be employed to perform various functionsin connection with the operation of the surgical instrument 4400. Forexample, as illustrated in FIG. 92, the surgical instrument 4400 mayinclude sensors A, B, and/or C. In certain instances, the sensor A canbe employed to perform a first function, for example; the sensor B canbe employed to perform a second function, for example; and the sensor Ccan be employed to perform a third function, for example. In certaininstances, the sensor A can be employed to sense a thickness of thetissue captured by the end effector 300 (FIGS. 1, 14) during a firstsegment of a closure stroke; the sensor B can be employed to sense thetissue thickness during a second segment of the closure stroke followingthe first segment; and the sensor C can be employed to sense the tissuethickness during a third segment of the closure stroke following thesecond segment, for example. In certain instances, the sensors A, B, andC can be disposed along the end effector 300, for example.

In certain instances, the sensors A, B, and C can be arranged, asillustrated in FIG. 94, such that the sensor A is disposed proximal tothe sensor B, and the sensor C is disposed proximal to the sensor B, forexample. In certain instances, as illustrated in FIG. 92, the sensor Acan sense the tissue thickness of the tissue captured by the endeffector 300 at a first position; the sensor B can sense the tissuethickness of the tissue captured by the end effector 300 at a secondposition distal to the first position; and the sensor C can sense thetissue thickness of the tissue captured by the end effector 300 at athird position distal to the second position, for example. The readerwill appreciate that the sensors described herein are intended asexamples of the types of sensors which can be employed in connectionwith the present disclosure. Other suitable sensors and sensingarrangements can be employed by the present disclosure.

In certain instances, the surgical instrument 4400 may include acontroller 4450 which can be similar in many respects to the commoncontroller 4410. For example, the controller 4450, like the commoncontroller 4410, may comprise the controller 4420, the processor 4422,and/or the memory 4424. In certain instances, the power source 4428 cansupply power to the controller 4450, for example. In certain instances,the surgical instrument 4400 may include a plurality of sensors such asthe sensors A, B, and C, for example, which can activated to performvarious functions in connection with the operation of the surgicalinstrument 4400. In certain instances, one of the sensors A, B, and C,for example, can be individually or separately activated to perform oneor more functions while the other sensors remain inactive. In certaininstances, a plurality of sensors of the surgical instrument 4400 suchas, for example, the sensors A, B, and C may share the controller 4450.In certain instances, only one of the sensors A, B, and C can be coupledto the controller 4450 at a time. In certain instances, the plurality ofsensors of the surgical instrument 4400 can be individually andseparately couplable to the controller 4450, for example. In at leastone example, the controller 4450 can be selectively switched betweenoperable engagement with sensor A, Sensor B, and/or Sensor C.

In certain instances, as illustrated in FIG. 92, the controller 4450 canbe disposed in the handle assembly 14, for example, and the sensors thatshare the controller 4450 can be disposed in the end effector 300 (FIGS.1, 14), for example. The reader will appreciate that the controller 4450and/or the sensors that share the controller 4450 are not limited to theabove identified positions. In certain instances, the controller 4450and the sensors that share the controller 4450 can be disposed in theend effector 300, for example. Other arrangements for the positions ofthe controller 4450 and/or the sensors that share the controller 4450are contemplated by the present disclosure.

In certain instances, as illustrated in FIG. 92, an interface 4452 canbe employed to manage the coupling and/or decoupling of the sensors ofthe surgical instrument 4400 to the controller 4450. In certaininstances, the interface 4452 can be selectively transitioned between aplurality of positions and/or states. In a first position and/or state,the interface 4452 may couple the controller 4450 to the sensor A, forexample; in a second position and/or state, the interface 4452 maycouple the controller 4450 to the sensor B, for example; and in a thirdposition and/or state, the interface 4452 may couple the controller 4450to the sensor C, for example. Additional positions and/or states of theinterface 4452 are contemplated by the present disclosure.

In certain instances, the interface 4452 is movable between a firstposition, a second position, and/or a third position, for example,wherein the controller 4450 is coupled to a first sensor in the firstposition, a second sensor in the second position, and a third sensor inthe third position. In certain instances, the controller 4450 isdecoupled from first sensor as the interface 4452 is moved from thefirst position; the controller 4450 is decoupled from second sensor asthe interface 4452 is moved from the second position; and the controller4450 is decoupled from third sensor as the interface 4452 is moved fromthe third position. In certain instances, a switch or a trigger can beconfigured to transition the interface 4452 between the plurality ofpositions and/or states. In certain instances, a trigger can be movableto simultaneously effectuate the end effector and transition thecontroller 4450 from operable engagement with one of the sensors thatshare the controller 4450 to operable engagement with another one of thesensors that share the controller 4450, for example.

In at least one example, as illustrated in FIG. 92, the closure trigger32 can be operably coupled to the interface 4452 and can be configuredto transition the interface 4452 between a plurality of positions and/orstates. As illustrated in FIG. 92, the closure trigger 32 can bemoveable between a plurality of positions, for example during a closurestroke, to transition the interface 4452 between a first position and/orstate wherein the controller 4450 is electrically coupled to the sensorA, for example, a second position and/or state wherein the controller4450 is electrically coupled to the sensor B, for example, and/or athird position and/or state wherein the controller 4450 is electricallycoupled to the sensor C, for example.

In certain instances, a user may actuate the closure trigger 32 tocapture tissue by the end effector 300. Actuation of the closure triggermay cause the interface 4452 to be transitioned or shifted to transitionthe controller 4450 from operable engagement with the sensor A, forexample, to operable engagement with the sensor B, for example, and/orfrom operable engagement with sensor B, for example, to operableengagement with sensor C, for example.

In certain instances, the controller 4450 may be coupled to the sensor Awhile the closure trigger 32 is in a first actuated position. As theclosure trigger 32 is actuated past the first actuated position andtoward a second actuated position, the controller 4450 may be decoupledfrom the sensor A. Alternatively, the controller 4450 may be coupled tothe sensor A while the closure trigger 32 is in an unactuated position.As the closure trigger 32 is actuated past the unactuated position andtoward a second actuated position, the controller 4450 may be decoupledfrom the sensor A. In certain instances, the controller 4450 may becoupled to the sensor B while the closure trigger 32 is in the secondactuated position. As the closure trigger 32 is actuated past the secondactuated position and toward a third actuated position, the controller4450 may be decoupled from the sensor B. In certain instances, thecontroller 4450 may be coupled to the sensor C while the closure trigger32 is in the third actuated position.

In certain instances, as illustrated in FIG. 92, the controller 4450 mayinclude a plurality of electrical and/or mechanical contacts 4451adapted for coupling engagement with the interface 4452. The pluralityof sensors of the surgical instrument 4400, which share the controller4450, may each comprise one or more corresponding electrical and/ormechanical contacts 4453 adapted for coupling engagement with theinterface 4452, for example.

In certain instances, the processor 4422 may receive input from theplurality of sensors that share the controller 4450 while the sensorsare coupled to the interface 4452. For example, the processor 4422 mayreceive input from the sensor A while the sensor A is coupled to thecontroller 4450; the processor 4422 may receive input from the sensor Bwhile the sensor B is coupled to the controller 4450; and the processor4422 may receive input from the sensor C while the sensor C is coupledto the controller 4450. In certain instances, the input can be ameasurement value such as, for example, a measurement value of a tissuethickness of tissue captured by the end effector 300 (FIGS. 1, 15). Incertain instances, the processor 4422 may store the input from one ormore of the sensors A, B, and C on the memory 4424. In certaininstances, the processor 4422 may perform various calculations based onthe input provided by the sensors A, B, and C, for example.

FIGS. 93A and 93B illustrate one aspect of an end effector 5300comprising a staple cartridge 5306 that further comprises twolight-emitting diodes 5310 (LEDs). FIG. 93A illustrates an end effector5300 comprising one LED 5310 located on either side of the cartridgedeck 5308. FIG. 91B illustrates a three-quarter angle view of the endeffector 5300 with the anvil 5302 in an open position, and one LED 5310located on either side of the cartridge deck 5308. The end effector 5300is similar to the end effector 300 (FIGS. 1, 15) described above. Theend effector comprises an anvil 5302, pivotally coupled to a jaw memberor elongated channel 5304. The elongated channel 5304 is configured toreceive the staple cartridge 5306 therein. The staple cartridge 5306comprises a plurality of staples (not shown). The plurality of staplesare deployable from the staple cartridge 5306 during a surgicaloperation. The staple cartridge 5306 further comprises two LEDs 5310mounted on the upper surface, or cartridge deck 5308 of the staplecartridge 5306. The LEDs 5310 are mounted such that they will be visiblewhen the anvil 5302 is in a closed position. Furthermore, the LEDs 5310can be sufficiently bright to be visible through any tissue that may beobscuring a direct view of the LEDs 5310. Additionally, one LED 5310 canbe mounted on either side of the staple cartridge 5306 such that atleast one LED 5310 is visible from either side of the end effector 5300.The LED 5310 can be mounted near the proximal end of the staplecartridge 530, as illustrated, or may be mounted at the distal end ofthe staple cartridge 5306.

The LEDs 5310 may be in communication with a processor or controller,such as, for instance, controller 1500 (FIG. 19). The controller 1500can be configured to detect a property of tissue compressed by the anvil5302 against the cartridge deck 5308. Tissue that is enclosed by the endeffector 5300 may change height as fluid within the tissue is exudedfrom the tissue's layers. Stapling the tissue before it has sufficientlystabilized may affect the effectiveness of the staples. Tissuestabilization is typically communicates as a rate of change, where therate of change indicates how rapidly the tissue enclosed by the endeffector is changing height.

The LEDs 5310 mounted to the staple cartridge 5306, in the view of theoperator of the instrument, can be used to indicate rate at which theenclosed tissue is stabilizing and/or whether the tissue has reached astable state. The LEDs 5310 can, for example, be configured to flash ata rate that directly correlates to the rate of stabilization of thetissue, that is, can flash quickly initially, flash slower as the tissuestabilizes, and remain steady when the tissue is stable. Alternatively,the LEDs 5310 can flash slowly initially, flash more quickly as thetissue stabilizes, and turn off when the tissue is stable.

The LEDs 5310 mounted on the staple cartridge 5306 can be usedadditionally or optionally to indicate other information. Examples ofother information include, but are not limited to: whether the endeffector 5300 is enclosing a sufficient amount of tissue, whether thestaple cartridge 5306 is appropriate for the enclosed tissue, whetherthere is more tissue enclosed than is appropriate for the staplecartridge 5306, whether the staple cartridge 5306 is not compatible withthe surgical instrument, or any other indicator that would be useful tothe operator of the instrument. The LEDs 5310 can indicate informationby either flashing at a particular rate, turning on or off at aparticular instance, lighting in different colors for differentinformation. The LEDs 5310 can alternatively or additionally be used toilluminate the area of operation. In some aspects the LEDs 5310 can beselected to emit ultraviolet or infrared light to illuminate informationnot visible under normal light, where that information is printed on thestaple cartridge located in the end effector 5300 or on a tissuecompensator (not illustrated). Alternatively or additionally, thestaples can be coated with a fluorescing dye and the wavelength of theLEDs 5310 chosen so that the LEDs 5310 cause the fluorescing dye toglow. By illuminating the staples with the LEDs 5310 allows the operatorof the instrument to see the staples after they have been driven.

FIGS. 94A and 94B illustrate one aspect of the end effector 5300comprising a staple cartridge 5356 that further comprises a plurality ofLEDs 5360. FIG. 92A illustrates a side angle view of the end effector5300 with the anvil 5302 in a closed position. The illustrated aspectcomprises, by way of example, a plurality of LEDs 5360 located on eitherside of the cartridge deck 5358. FIG. 92B illustrates a three-quarterangle view of the end effector 5300 with the anvil 5302 in an openposition, illustrating a plurality of LEDs 5360 located on either sideof the cartridge deck 5358. The staple cartridge 5356 comprises aplurality of LEDs 5360 mounted on the cartridge deck 5358 of the staplecartridge 5356. The LEDs 5360 are mounted such that they will be visiblewhen the anvil 5302 is in a closed position. Furthermore, the LEDs 6 530can be sufficiently bright to be visible through any tissue that may beobscuring a direct view of the LEDs 5360. Additionally, the same numberof LEDs 5360 can be mounted on either side of the staple cartridge 5356such that the same number of LEDs 5360 is visible from either side ofthe end effector 5300. The LEDs 5360 can be mounted near the proximalend of the staple cartridge 5356, as illustrated, or may be mounted atthe distal end of the staple cartridge 5356.

The LEDs 5360 may be in communication with a processor or controller,such as, for instance, controller 1500 of FIG. 15. The controller 1500can be configured to detect a property of tissue compressed by the anvil5302 against the cartridge deck 5358, such as the rate of stabilizationof the tissue, as described above. The LEDs 5360 can be used to indicatethe rate at which the enclose tissue is stabilizing and/or whether thetissue has reached a stable state. The LEDs 5360 can be configured, forinstance, to light in sequence starting at the proximal end of thestaple cartridge 5356 with each subsequent LED 5360 lighting at the rateat which the enclosed tissue is stabilizing; when the tissue is stable,all the LEDs 5360 can be lit. Alternatively, the LEDs 5360 can light insequence beginning at the distal end of the staple cartridge 5356. Yetanother alternative is for the LEDs 5360 to light in a sequential,repeating sequence, with the sequence starting at either the proximal ordistal end of the LEDs 5360. The rate at which the LEDs 5360 lightand/or the speed of the repeat can indicate the rate at which theenclosed tissue is stabilizing. It is understood that these are onlyexamples of how the LEDs 5360 can indicate information about the tissue,and that other combinations of the sequence in which the LEDs 5360light, the rate at which they light, and or their on or off state arepossible. It is also understood that the LEDs 5360 can be used tocommunicate some other information to the operator of the surgicalinstrument, or to light the work area, as described above.

FIGS. 95A and 95B illustrate one aspect of the end effector 5300comprising a staple cartridge 5406 that further comprises a plurality ofLEDs 5410. FIG. 93A illustrates a side angle view of the end effector5300 with the anvil 5302 in a closed position. The illustrated aspectcomprises, by way of example, a plurality of LEDs 5410 from the proximalto the distal end of the staple cartridge 5406, on either side of thecartridge deck 5408. FIG. 93B illustrates a three-quarter angle view ofthe end effector 5300 with the anvil 5302 in an open position,illustrating a plurality of LEDs 5410 from the proximal to the distalend of the staple cartridge 5406, and on either side of the cartridgedeck 5408. The staple cartridge 5406 comprises a plurality of LEDs 5410mounted on the cartridge deck 5408 of the staple cartridge 5406, withthe LEDs 5410 placed continuously from the proximal to the distal end ofthe staple cartridge 5406. The LEDs 5410 are mounted such that they willbe visible when the anvil 5302 is in a closed position. The same numberof LEDs 5410 can be mounted on either side of the staple cartridge 5406such that the same number of LEDs 5410 is visible from either side ofthe end effector 5300.

The LEDs 5410 can be in communication with a processor or controller,such as, for instance, controller 1500 of FIG. 15. The controller 1500can be configured to detect a property of tissue compressed by the anvil5302 against the cartridge deck 5408, such as the rate of stabilizationof the tissue, as described above. The LEDs 5410 can be configured to beturned on or off in sequences or groups as desired to indicate the rateof stabilization of the tissue and/or that the tissue is stable. TheLEDs 5410 can further be configured communicate some other informationto the operator of the surgical instrument, or to light the work area,as described above. Additionally or alternatively, the LEDs 5410 can beconfigured to indicate which areas of the end effector 5300 containstable tissue, and or what areas of the end effector 5300 are enclosingtissue, and/or if those areas are enclosing sufficient tissue. The LEDs5410 can further be configured to indicate if any portion of theenclosed tissue is unsuitable for the staple cartridge 5406.

Referring now primarily to FIGS. 96 and 97, the power assembly 2096 mayinclude a power modulator control 2106 which may comprise, for example,one or more field-effect transistors (FETs), a Darlington array, anadjustable amplifier, and/or any other power modulator. The powerassembly controller 2100 may actuate the power modulator control 2106 toset the power output of the battery 2098 to the power requirement of theinterchangeable working assembly 2094 in response to the signalgenerated by working assembly controller 2102 while the interchangeableworking assembly 2094 is coupled to the power assembly 2096.

Still referring primarily to FIGS. 96 and 97, the power assemblycontroller 2100 can be configured to monitor power transmission from thepower assembly 2096 to the interchangeable working assembly 2094 for theone or more signals generated by the working assembly controller 2102 ofthe interchangeable working assembly 2094 while he interchangeableworking assembly 2094 is coupled to the power assembly 2096. Asillustrated in FIG. 96, the power assembly controller 2100 may utilize avoltage monitoring mechanism for monitoring the voltage across thebattery 2098 to detect the one or more signals generated by the workingassembly controller 2102, for example. In certain instances, a voltageconditioner can be utilized to scale the voltage of the battery 2098 tobe readable by an Analog to Digital Converter (ADC) of the powerassembly controller 2100. As illustrated in FIG. 96, the voltageconditioner may comprise a voltage divider 2108 which can create areference voltage or a low voltage signal proportional to the voltage ofthe battery 2098 which can be measured and reported to the powerassembly controller 2100 through the ADC, for example.

In other circumstances, as illustrated in FIG. 97, the power assembly2096 may comprise a current monitoring mechanism for monitoring currenttransmitted to the interchangeable working assembly 2094 to detect theone or more signals generated by the working assembly controller 2102,for example. In certain instances, the power assembly 2096 may comprisea current sensor 2110 which can be utilized to monitor currenttransmitted to the interchangeable working assembly 2094. The monitoredcurrent can be reported to the power assembly controller 2100 through anADC, for example. In other circumstances, the power assembly controller2100 may be configured to simultaneously monitor both of the currenttransmitted to the interchangeable working assembly 2094 and thecorresponding voltage across the battery 2098 to detect the one or moresignals generated by the working assembly controller 2102. The readerwill appreciate that various other mechanisms for monitoring currentand/or voltage can be utilized by the power assembly controller 2100 todetect the one or more signals generated by the working assemblycontroller 2102; all such mechanisms are contemplated by the presentdisclosure.

Referring to FIG. 98, the controller 13002 may generally comprise aprocessor 13008 (“microprocessor”) and one or more memory units 13010operationally coupled to the processor 13008. By executing instructioncode stored in the memory 13010, the processor 13008 may control variouscomponents of the surgical instrument 12200, such as the motor 12216,various drive systems, and/or a user display, for example. Thecontroller 13002 may be implemented using integrated and/or discretehardware elements, software elements, and/or a combination of both.Examples of integrated hardware elements may include processors,microprocessors, controllers, integrated circuits, application specificintegrated circuits (ASIC), programmable logic devices (PLD), digitalsignal processors (DSP), field programmable gate arrays (FPGA), logicgates, registers, semiconductor devices, chips, microchips, chip sets,controllers, system-on-chip (SoC), and/or system-in-package (SIP).Examples of discrete hardware elements may include circuits and/orcircuit elements such as logic gates, field effect transistors, bipolartransistors, resistors, capacitors, inductors, and/or relays. In certaininstances, the controller 13002 may include a hybrid circuit comprisingdiscrete and integrated circuit elements or components on one or moresubstrates, for example. In certain instances, the controller 13002 maybe a single core or multicore controller LM4F230H5QR as described inconnection with FIGS. 15-17B.

In various forms, the motor 12216 may be a DC brushed driving motorhaving a maximum rotation of, approximately, 25,000 RPM, for example. Inother arrangements, the motor 12216 may include a brushless motor, acordless motor, a synchronous motor, a stepper motor, or any othersuitable electric motor. A battery 12218 (or “power source” or “powerpack”), such as a Li ion battery, for example, may be coupled to thehousing 12212 to supply power to the motor 12216, for example.

Referring again to FIG. 98, the surgical instrument 12200 may include amotor controller 13005 in operable communication with the controller13002. The motor controller 13005 can be configured to control adirection of rotation of the motor 12216. In certain instances, themotor controller 13005 may be configured to determine the voltagepolarity applied to the motor 12216 by the battery 12218 and, in turn,determine the direction of rotation of the motor 12216 based on inputfrom the controller 13002. For example, the motor 12216 may reverse thedirection of its rotation from a clockwise direction to acounterclockwise direction when the voltage polarity applied to themotor 12216 by the battery 12218 is reversed by the motor controller13005 based on input from the controller 13002. In addition, the motor12216 can be operably coupled to an articulation drive which can bedriven by the motor 12216 distally or proximally depending on thedirection in which the motor 12216 rotates, for example. Furthermore,the articulation drive can be operably coupled to the end effector 12208such that, for example, the axial translation of the articulation driveproximally may cause the end effector 12208 to be articulated in thecounterclockwise direction, for example, and/or the axial translation ofthe articulation drive distally may cause the end effector 12208 to bearticulated in the clockwise direction, for example.

In the aspect illustrated in FIG. 99, an interface 3001 comprisesmultiple switches 3004A-C, 3084B wherein each of the switches 3004A-C iscoupled to the controller 3002 via one of three electrical circuits3006A-C, respectively, and switch 3084B is coupled to the controller3002 via circuit 3084A. The reader will appreciate that othercombinations of switches and circuits can be utilized with the interface3001.

Further to the above, the controller 3002 may comprise a processor 3008and/or one or more memory 3010 units. By executing instruction codestored in the memory 3010, the processor 3008 may control variouscomponents of the surgical instrument, such as the electric motor 1102and/or a user display. The controller 3002 may be implemented usingintegrated and/or discrete hardware elements, software elements, and/ora combination of both. Examples of integrated hardware elements mayinclude processors, microprocessors, controllers, integrated circuits,application specific integrated circuits (ASIC), programmable logicdevices (PLD), digital signal processors (DSP), field programmable gatearrays (FPGA), logic gates, registers, semiconductor devices, chips,microchips, chip sets, controller, system-on-chip (SoC), and/orsystem-in-package (SIP). Examples of discrete hardware elements mayinclude circuits and/or circuit elements (e.g., logic gates, fieldeffect transistors, bipolar transistors, resistors, capacitors,inductors, relay and so forth). In other aspects, the controller 3002may include a hybrid circuit comprising discrete and integrated circuitelements or components on one or more substrates, for example.

Referring again to FIG. 99, the surgical instrument 1010 may include amotor controller 3005 in operable communication with the controller3002. The motor controller 3005 can be configured to control a directionof rotation of the electric motor 1102. For example, the electric motor1102 can be powered by a battery such as, for example, the battery 1104and the controller 3002 may be configured to determine the voltagepolarity applied to the electric motor 1102 by the battery 1104 and, inturn, the direction of rotation of the electric motor 1102 based oninput from the controller 3002. For example, the electric motor 1102 mayreverse the direction of its rotation from a clockwise direction to acounterclockwise direction when the voltage polarity applied to theelectric motor 1102 by the battery 1104 is reversed by the motorcontroller 3005 based on input from the controller 3002. Examples ofsuitable motor controllers are described elsewhere in this document andinclude but are not limited to the driver 7010 (FIG. 100).

In addition, as described elsewhere in this document in greater detail,the electric motor 1102 can be operably coupled to an articulationdrive. In use, the electric motor 1102 can drive the proximalarticulation drive distally or proximally depending on the direction inwhich the electric motor 1102 rotates. Furthermore, the proximalarticulation drive can be operably coupled to the end effector 1300 suchthat, for example, the axial translation of the proximal articulationdrive 10030 proximally may cause the end effector 1300 to be articulatedin the counterclockwise direction, for example, and/or the axialtranslation of the proximal articulation drive 10030 distally may causethe end effector 1300 to be articulated in the clockwise direction, forexample.

Further to the above, referring again to FIG. 99, the interface 3001 canbe configured such that the switch 3004A can be dedicated to clockwisearticulation of the end effector 1300 and the switch 3004B can bededicated to counterclockwise articulation of the end effector 1300. Forexample, the operator may articulate the end effector 1300 in theclockwise direction by closing the switch 3004A which may signal thecontroller 3002 to cause the electric motor 1102 to rotate in theclockwise direction thereby, as a result, causing the proximalarticulation drive 10030 to be advanced distally and causing the endeffector 1300 to be articulated in the clockwise direction. In anotherexample, the operator may articulate the end effector 1300 in thecounterclockwise direction by closing the switch 3004B which may signalthe controller 3002 to cause the electric motor 1102 to rotate in thecounterclockwise direction, for example, and retracting the proximalarticulation drive 10030 proximally to articulate the end effector 1300to in the counterclockwise direction.

As shown in FIG. 100, a sensor arrangement 7002 provides a uniqueposition signal corresponding to the location of thelongitudinally-movable drive member 1111. The electric motor 1102 caninclude a rotatable shaft 7016 that operably interfaces with a gearassembly 7014 that is mounted in meshing engagement with a with a set,or rack, of drive teeth on the longitudinally-movable drive member 1111.With reference also to FIG. 101, the sensor element 7026 may be operablycoupled to the gear assembly 7106 such that a single revolution of thesensor element 7026 corresponds to some linear longitudinal translationof the longitudinally-movable drive member 1111, as described in moredetail hereinbelow. In one aspect, an arrangement of gearing and sensorscan be connected to the linear actuator via a rack and pinionarrangement, or a rotary actuator via a spur gear or other connection.For aspects comprising a rotary screw-drive configuration where a largernumber of turns would be required, a high reduction gearing arrangementbetween the drive member and the sensor, like a worm and wheel, may beemployed.

In accordance one aspect of the present disclosure, the sensorarrangement 7002 for the absolute positioning system 7000 provides aposition sensor 7012 that is more robust for use with surgical devices.By providing a unique position signal or value for each possibleactuator position, such arrangement eliminates the need for a zeroing orcalibration step and reduces the possibility of negative design impactin the cases where noise or power brown-out conditions may createposition sense errors as in conventional rotary encoder configurations.

In one aspect, the sensor arrangement 7002 for the absolute positioningsystem 7000 replaces conventional rotary encoders typically attached tothe motor rotor and replaces it with a position sensor 7012 whichgenerates a unique position signal for each rotational position in asingle revolution of a sensor element associated with the positionsensor 7012. Thus, a single revolution of a sensor element associatedwith the position sensor 7012 is equivalent to a longitudinal lineardisplacement d1 of the of the longitudinally-movable drive member 1111.In other words, d1 is the longitudinal linear distance that thelongitudinally-movable drive member 1111 moves from point “a” to point“b” after a single revolution of a sensor element coupled to thelongitudinally-movable drive member 1111. The sensor arrangement 7002may be connected via a gear reduction that results in the positionsensor 7012 completing only a single turn for the full stroke of thelongitudinally-movable drive member 1111. With a suitable gear ratio,the full stroke of the longitudinally-movable drive member 1111 can berepresented in one revolution of the position sensor 7012.

A series of switches 7022 a to 7022 n, where n is an integer greaterthan one, may be employed alone or in combination with gear reduction toprovide a unique position signal for more than one revolution of theposition sensor 7012. The state of the switches 7022 a-7022 n are fedback to a controller 7004 which applies logic to determine a uniqueposition signal corresponding to the longitudinal linear displacementd1+d2+ . . . dn of the longitudinally-movable drive member 1111.

Accordingly, the absolute positioning system 7000 provides an absoluteposition of the longitudinally-movable drive member 1111 upon power upof the instrument without retracting or advancing thelongitudinally-movable drive member 1111 to a reset (zero or home)position as may be required with conventional rotary encoders thatmerely count the number of steps forwards or backwards that motor hastaken to infer the position of a device actuator, drive bar, knife, andthe like.

In various aspects, the position sensor 7012 of the sensor arrangement7002 may comprise one or more magnetic sensor, analog rotary sensor likea potentiometer, array of analog Hall-effect elements, which output aunique combination of position signals or values, among others, forexample.

In various aspects, the controller 7004 may be programmed to performvarious functions such as precise control over the speed and position ofthe knife and articulation systems. Using the known physical properties,the controller 7004 can be designed to simulate the response of theactual system in the software of the controller 7004. The simulatedresponse is compared to (noisy and discrete) measured response of theactual system to obtain an “observed” response, which is used for actualfeedback decisions. The observed response is a favorable, tuned, valuethat balances the smooth, continuous nature of the simulated responsewith the measured response, which can detect outside influences on thesystem.

In various aspects, the absolute positioning system 7000 may furthercomprise and/or be programmed to implement the followingfunctionalities. A feedback controller, which can be one of any feedbackcontrollers, including, but not limited to: PID, state feedback andadaptive. A power source converts the signal from the feedbackcontroller into a physical input to the system, in this case voltage.Other examples include, but are not limited to pulse width modulated(PWMed) voltage, current and force. The electric motor 1102 may be abrushed DC motor with a gearbox and mechanical links to an articulationor knife system. Other sensor(s) 7018 may be provided to measurephysical parameters of the physical system in addition to positionmeasured by the position sensor 7012. Since it is a digital signal (orconnected to a digital data acquisition system) its output will havefinite resolution and sampling frequency. A compare and combine circuitmay be provided to combine the simulated response with the measuredresponse using algorithms such as, without limitation, weighted averageand theoretical control loop that drives the simulated response towardsthe measured response. Simulation of the physical system takes inaccount of properties like mass, inertial, viscous friction, inductanceresistance, etc. to predict what the states and outputs of the physicalsystem will be by knowing the input. In one aspect, the controller 7004may be a single core or multicore controller LM4F230H5QR as described inconnection with FIGS. 15-17B.

In one aspect, the driver 7010 may be a A3941 available from AllegroMicrosystems, Inc. The A3941 driver 7010 is a full-bridge controller foruse with external N-channel power metal oxide semiconductor field effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 7010 comprises a unique charge pumpregulator provides full (>10 V) gate drive for battery voltages down to7 V and allows the A3941 to operate with a reduced gate drive, down to5.5 V. A bootstrap capacitor may be employed to provide theabove-battery supply voltage required for N-channel MOSFETs. An internalcharge pump for the high-side drive allows DC (100% duty cycle)operation. The full bridge can be driven in fast or slow decay modesusing diode or synchronous rectification. In the slow decay mode,current recirculation can be through the high-side or the lowside FETs.The power FETs are protected from shoot-through by resistor adjustabledead time. Integrated diagnostics provide indication of undervoltage,overtemperature, and power bridge faults, and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the absolutepositioning system 7000. Accordingly, the present disclosure should notbe limited in this context.

Having described a general architecture for implementing various aspectsof an absolute positioning system 7000 for a sensor arrangement 7002,the disclosure now turns to FIGS. 101-103 for a description of oneaspect of a sensor arrangement for the absolute positioning system 7000.In the aspect illustrated in FIG. 101, the sensor arrangement 7002comprises a position sensor 7100, a magnet 7102 sensor element, a magnetholder 7104 that turns once every full stroke of thelongitudinally-movable drive member 1111 (FIG. 100), and a gear assembly7106 to provide a gear reduction. A structural element such as bracket7116 is provided to support the gear assembly 7106, the magnet holder7104, and the magnet 7102. The position sensor 7100 comprises one ormore than one magnetic sensing elements such as Hall elements and isplaced in proximity to the magnet 7102. Accordingly, as the magnet 7102rotates, the magnetic sensing elements of the position sensor 7100determine the absolute angular position of the magnet 7102 over onerevolution.

In various aspects, any number of magnetic sensing elements may beemployed on the absolute positioning system 7000, such as, for example,magnetic sensors classified according to whether they measure the totalmagnetic field or the vector components of the magnetic field. Thetechniques used to produce both types of magnetic sensors encompass manyaspects of physics and electronics. The technologies used for magneticfield sensing include search coil, fluxgate, optically pumped, nuclearprecession, SQUID, Hall-effect, anisotropic magnetoresistance, giantmagnetoresistance, magnetic tunnel junctions, giant magnetoimpedance,magnetostrictive/piezoelectric composites, magnetodiode,magnetotransistor, fiber optic, magnetooptic, and microelectromechanicalsystems-based magnetic sensors, among others.

In the illustrated aspect, the gear assembly 7106 comprises a first gear7108 and a second gear 7110 in meshing engagement to provide a 3:1 gearratio connection. A third gear 7112 rotates about shaft 7114. The thirdgear is in meshing engagement with the longitudinally-movable drivemember 1111 and rotates in a first direction as thelongitudinally-movable drive member 1111 advances in a distal directionD and rotates in a second direction as the longitudinally-movable drivemember 1111 retracts in a proximal direction P. The second gear 7110also rotates about the shaft 7114 and therefore, rotation of the secondgear 7110 about the shaft 7114 corresponds to the longitudinaltranslation of the longitudinally-movable drive member 1111. Thus, onefull stroke of the longitudinally-movable drive member 1111 in eitherthe distal or proximal directions D, P corresponds to three rotations ofthe second gear 7110 and a single rotation of the first gear 7108. Sincethe magnet holder 7104 is coupled to the first gear 7108, the magnetholder 7104 makes one full rotation with each full stroke of thelongitudinally-movable drive member 1111.

FIG. 102 is an exploded perspective view of the sensor arrangement 7002for the absolute positioning system 7000 showing a circuit 1106 and therelative alignment of the elements of the sensor arrangement 7002,according to one aspect. The position sensor 7100 (not shown in thisview) is supported by a position sensor holder 7118 defining an aperture7120 suitable to contain the position sensor 7100 in precise alignmentwith a magnet 7102 rotating below. The fixture is coupled to the bracket7116 and to the circuit 1106 and remains stationary while the magnet7102 rotates with the magnet holder 7104. A hub 7122 is provided to matewith the first gear 7108 and the magnet holder 7104.

FIG. 103 is a schematic diagram of one aspect of a position sensor 7100sensor for an absolute positioning system 7000 comprising a magneticrotary absolute positioning system, according to one aspect. In oneaspect, the position sensor 7100 may be implemented as an AS5055EQFTsingle-chip magnetic rotary position sensor available from AustriaMicrosystems, AG. The position sensor 7100 is interfaced with thecontroller 7004 to provide an absolute positioning system 7000. Theposition sensor 7100 is a low voltage and low power component andincludes four Hall-effect elements 7128A, 7128B, 7128C, 7128D in an area7130 of the position sensor 7100 that is located above the magnet 7102(FIGS. 99, 100). A high resolution ADC 7132 and a smart power managementcontroller 7138 are also provided on the chip. A CORDIC processor 7136(for COordinate Rotation DIgital Computer), also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits and magnetic fieldinformation are transmitted over a standard serial communicationinterface such as an SPI interface 7134 to the controller 7004. Theposition sensor 7100 provides 12 or 14 bits of resolution. The positionsensor 7100 may be an AS5055 chip provided in a small QFN 16-pin4×4×0.85 mm package.

The Hall-effect elements 7128A, 7128B, 7128C, 7128D are located directlyabove the rotating magnet. The Hall-effect is a well known effect andwill not be described in detail herein for the sake of conciseness andclarity of disclosure. Generally, the Hall-effect is the production of avoltage difference (the Hall voltage) across an electrical conductor,transverse to an electric current in the conductor and a magnetic fieldperpendicular to the current. It was discovered by Edwin Hall in 1879.The Hall coefficient is defined as the ratio of the induced electricfield to the product of the current density and the applied magneticfield. It is a characteristic of the material from which the conductoris made, since its value depends on the type, number, and properties ofthe charge carriers that constitute the current. In the AS5055 positionsensor 7100, the Hall-effect elements 7128A, 7128B, 7128C, 7128D arecapable producing a voltage signal that is indicative of the absoluteposition of the magnet 7102 (FIGS. 186, 187) in terms of the angle overa single revolution of the magnet 7102. This value of the angle, whichis unique position signal, is calculated by the CORDIC processor 7136 isstored onboard the AS5055 position sensor 7100 in a register or memory.The value of the angle that is indicative of the position of the magnet7102 over one revolution is provided to the controller 7004 in a varietyof techniques, e.g., upon power up or upon request by the controller7004.

The AS5055 position sensor 7100 requires only a few external componentsto operate when connected to the controller 7004. Six wires are neededfor a simple application using a single power supply: two wires forpower and four wires 7140 for the SPI interface 7134 with the controller7004. A seventh connection can be added in order to send an interrupt tothe controller 7004 to inform that a new valid angle can be read.

Upon power-up, the AS5055 position sensor 7100 performs a full power-upsequence including one angle measurement. The completion of this cycleis indicated as an INT output 7142 and the angle value is stored in aninternal register. Once this output is set, the AS5055 position sensor7100 suspends to sleep mode. The controller 7004 can respond to the INTrequest at the INT output 7142 by reading the angle value from theAS5055 position sensor 7100 over the SPI interface 7134. Once the anglevalue is read by the controller 7004, the INT output 7142 is clearedagain. Sending a “read angle” command by the SPI interface 7134 by thecontroller 7004 to the position sensor 7100 also automatically powers upthe chip and starts another angle measurement. As soon as the controller7004 has completed reading of the angle value, the INT output 7142 iscleared and a new result is stored in the angle register. The completionof the angle measurement is again indicated by setting the INT output7142 and a corresponding flag in the status register.

Due to the measurement principle of the AS5055 position sensor 7100,only a single angle measurement is performed in very short time (˜600μs) after each power-up sequence. As soon as the measurement of oneangle is completed, the AS5055 position sensor 7100 suspends topower-down state. An on-chip filtering of the angle value by digitalaveraging is not implemented, as this would require more than one anglemeasurement and consequently, a longer power-up time which is notdesired in low power applications. The angle jitter can be reduced byaveraging of several angle samples in the controller 7004. For example,an averaging of 4 samples reduces the jitter by 6 dB (50%).

As discussed above, the electric motor 1102 positioned within the handle1042 of surgical instrument system 1000 can be utilized to advanceand/or retract the firing system of the shaft assembly 1200, includingfiring members 1272 and 1280, for example, relative to the end effector1300 of the shaft assembly 1200 in order to staple and/or incise tissuecaptured within the end effector 1300. In various circumstances, it maybe desirable to advance the firing members 1272 and 1280 at a desiredspeed, or within a range of desired speeds. Likewise, it may bedesirable to retract the firing members 1272 and 1280 at a desiredspeed, or within a range of desired speeds. In various circumstances,the controller 7004 of the handle 1042, for example, and/or any othersuitable controller, can be configured to control the speed of thefiring members 1272 and 1280. In some circumstances, the controller canbe configured to predict the speed of the firing members 1272 and 1280based on various parameters of the power supplied to the electric motor1102, such as voltage and/or current, for example, and/or otheroperating parameters of the electric motor 1102. The controller can alsobe configured to predict the current speed of the firing members 1272and 1280 based on the previous values of the current and/or voltagesupplied to the electric motor 1102, and/or previous states of thesystem like velocity, acceleration, and/or position. Furthermore, thecontroller can also be configured to sense the speed of the firingmembers 1272 and 1280 utilizing the absolute positioning sensor systemdescribed above, for example. In various circumstances, the controllercan be configured to compare the predicted speed of the firing members1272 and 1280 and the sensed speed of the firing members 1272 and 1280to determine whether the power to the electric motor 1102 should beincreased in order to increase the speed of the firing members 1272 and1280 and/or decreased in order to decrease the speed of the firingmembers 1272 and 1280. U.S. Pat. No. 8,210,411, entitled MOTOR-DRIVENSURGICAL CUTTING INSTRUMENT, which is incorporated herein by referencein its entirety. U.S. Pat. No. 7,845,537, entitled SURGICAL INSTRUMENTHAVING RECORDING CAPABILITIES, which is incorporated herein by referencein its entirety.

Using the physical properties of the instruments disclosed herein,turning now to FIGS. 104 and 105, a controller, such as controller 7004,for example, can be designed to simulate the response of the actualsystem of the instrument in the software of the controller. Thesimulated response is compared to a (noisy and discrete) measuredresponse of the actual system to obtain an “observed” response, which isused for actual feedback decisions. The observed response is afavorable, tuned, value that balances the smooth, continuous nature ofthe simulated response with the measured response, which can detectoutside influences on the system. With regard to FIGS. 104 and 105, afiring element, or cutting element, in the end effector 1300 of theshaft assembly 1200 can be moved at or near a target velocity, or speed.The systems disclosed in FIGS. 102 and 103 can be utilized to move thecutting element at a target velocity. The systems can include a feedbackcontroller 4200, which can be one of any feedback controllers,including, but not limited to a PID, a State Feedback, LQR, and/or anAdaptive controller, for example. The systems can further include apower source. The power source can convert the signal from the feedbackcontroller 4200 into a physical input to the system, in this casevoltage, for example. Other examples include, but are not limited to,pulse width modulated (PWM) voltage, frequency modulated voltage,current, torque, and/or force, for example.

With continued reference to FIGS. 104 and 105, the physical systemreferred to therein is the actual drive system of the instrumentconfigured to drive the firing member, or cutting member. One example isa brushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 1102disclosed herein that operates the firing member 10060 and thearticulation driver 10030, for example, of an interchangeable shaftassembly. The outside influence 4201 referred to in FIGS. 104 and 105 isthe unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system, for example.Such outside influence can be referred to as drag and can be representedby a motor 4202 which acts in opposition to the electric motor 1102, forexample. In various circumstances, outside influence, such as drag, isthe primary cause for deviation of the simulation of the physical systemfrom the actual physical system. The systems depicted in FIGS. 104 and105 and further discussed below can address the differences between thepredicted behavior of the firing member, or cutting member, and theactual behavior of the firing member, or cutting member.

With continued reference to FIGS. 104 and 105, the discrete sensorreferred to therein measures physical parameters of the actual physicalsystem. One aspect of such a discrete sensor can include an absolutepositioning sensor and system described herein, such as the magnet 7102.As the output of such a discrete sensor can be a digital signal (orconnected to a digital data acquisition system) its output may havefinite resolution and sampling frequency. The output of the discretesensor can be supplied to a controller, such as controller 7004, forexample. In various circumstances, the controller can combine thesimulated, or estimated, response with the measured response. In certaincircumstances, it may be useful to use enough measured response toensure that the outside influence is accounted for without making theobserved response unusably noisy. Examples for algorithms that do soinclude a weighted average and/or a theoretical control loop that drivesthe simulated response towards the measured response, for example.Ultimately, further to the above, the simulation of the physical systemtakes in account of properties like mass, inertial, viscous friction,and/or inductance resistance, for example, to predict what the statesand outputs of the physical system will be by knowing the input. FIG.103 shows an addition of evaluating and measuring the current suppliedto operate the actual system, which is yet another parameter that can beevaluated for controlling the speed of the cutting member, or firingmember, of the shaft assembly 1200, for example. By measuring current inaddition to or in lieu of measuring the voltage, in certaincircumstances, the physical system can be made more accurate.Nonetheless, the ideas disclosed herein can be extended to themeasurement of other state parameters of other physical systems.

FIG. 106 illustrates a perspective view of a surgical instrument 5500according to various aspects described herein. The surgical instrument5500 is similar to those described hereinabove in that the surgicalinstrument 5500 includes an elongated channel configured to support astaple cartridge, an anvil pivotably connected to the elongated channel,a closure member mechanically coupled to the anvil, a knife mechanicallycoupled to the staple cartridge, an electric motor mechanically coupledto the closure member and/or the knife, a motor controller electricallycoupled to the motor, and a control circuit electrically coupled to themotor controller. The surgical instrument 5500 is also similar to thosedescribed hereinabove in that the surgical instrument 5500 also includessensors which are collectively configured to sense or measure a closingforce, a firing force, a current drawn by the electric motor, animpedance of tissue positioned between the elongated channel and theanvil, a position of the anvil relative to the elongated channel, aposition of the knife, or any combination thereof. The surgicalinstrument 5500 is also similar to those described hereinabove in thatthe surgical instrument 5500 also includes algorithms such as closingalgorithms, firing algorithms, motor control algorithms, or anycombination thereof, which operate to dynamically adjust the operationof the surgical instrument 5500. However, the surgical instrument 5500is different from those described hereinabove in that the surgicalinstrument 5500 further includes one or more additional algorithms (inaddition to those described hereinabove) which provide additionalcontrol functionality for the surgical instrument 5500, as describedhereinbelow.

In general, the surgical instrument 5500 may utilize one or more closingalgorithms to control a closing motion which clamps the jaws to tissuepositioned therebetween and/or one or more firing algorithms to controla firing motion which staples and severs the tissue clamped between thejaws. In operation, a given sensor senses or measures a given parameter(e.g., a closing force, a firing force, and/or any combination thereof)and outputs a signal indicative of the sensed/measured parameter. Theoutput signal can be an analog signal or a digital signal. For instanceswhere the signal output by the sensor is an analog signal, the analogsignal is input to an analog-to-digital (A/D) converter which outputs adigital signal indicative of the analog signal. The digital signal isthen input to a controller resident in the surgical instrument 5500. Forinstances where the signal output by the sensor is a digital signal,there is no need for an A/D conversion and the digital signal output bythe sensor can be input to the controller. Upon the occurrence of atrigger, a threshold and/or an event, the controller may modify oradjust a closing algorithm, or initiate a different closing algorithm,thereby automatically changing the operation of the surgical instrument5500 during a closing motion. Similarly, upon the occurrence of atrigger, a threshold and/or an event, the controller may modify oradjust a firing algorithm, or initiate a different firing algorithm,thereby automatically changing the operation of the surgical instrument5500 during a firing motion.

According to various aspects, the trigger, threshold or event is definedby the sensed/measured closing force. According to other aspects, thetrigger, threshold or event is defined by a parameter related to thesensed/measured closing force. Similarly, according to various aspects,the trigger, threshold or event is defined by the sensed/measured firingforce. According to other aspects, the trigger, threshold or event isdefined by a parameter related to the sensed/measured firing force.

FIG. 107 illustrates a method 1010 of controlling a closing motion ofthe surgical instrument 5500 according to various aspects. The processstarts when a closing motion is initiated 5512. The closing motion maybe initiated, for example, by pulling a closing trigger toward a handle.A sensor resident with the surgical instrument 5500 senses/measures 5514a closing force. The closing force may be, for example, a forceexperienced by tissue clamped between the jaws of the surgicalinstrument 5500, a force experienced by the jaws of the surgicalinstrument 5500 (e.g., by the anvil and/or the elongated channel), aforce experienced by the closure tube of the surgical instrument 5500,and/or any combinations thereof.

In response to the closing force, the sensor outputs 5516 a closingforce signal, which is indicative of the closing force sensed/measured5514 by the sensor. Depending on the configuration of the sensor, theclosing force signal can be an analog signal or a digital signal. Upondetermining 5518 whether the closing force signal is either an analogsignal or a digital signal, the process proceeds along the correspondingbranch. When the determination 5518 is that the closing force signal isan analog signal, the process proceeds along the analog branch, wherethe analog signal is received by an A/D converter, converted 5520 to adigital signal representative of the analog signal by the A/D converterand the digital signal is output by the A/D converter. When thedetermination 5518 is that the closing force signal is a digital signal,the process proceeds along the digital branch because there is no needfor an A/D conversion 5520 when the closing force signal is a digitalsignal.

The closing force signal which is a digital signal representative of theclosing force sensed/measured 5514 by the sensor is received by acontroller. The controller utilizes the digital signal and determines5522 whether the closing force sensed/measured 5514 by the sensorreaches or exceeds a predetermined threshold. The controller may makethis determination 5522 based on a comparison of a magnitude of theclosing force sensed/measured 5514 by the sensor and the predeterminedthreshold, based on a comparison of an amplitude of the closing forcesignal output 5516 by the sensor and a predetermined threshold, or anycombination thereof.

When the controller determines 5522 that the closing forcesensed/measured 5514 by the sensor has not reached or exceeded thepredetermined threshold, the closing motion originally initiated 5512 iscontinued 5524 along with interim processes 5514-5522. When thecontroller determines 5522 that the closing force sensed/measured 5514by the sensor has reached or exceeded the predetermined threshold, thecontroller changes 5526 the closing motion. According to some aspects,the controller may change the closing motion by modifying or adjusting aclosing algorithm being executed by the controller to cause the closingmotion to be slowed down, paused or stopped to prevent the surgicalinstrument 5500 from experiencing excessive forces. According to otheraspects, the controller may change the closing motion by executing adifferent closing algorithm which causes the closing motion to be sloweddown, paused or stopped to prevent the surgical instrument 5500 fromexperiencing excessive forces. In either case, the closing motion may beslowed down, stopped or paused by having the controller communicate aslow down signal, a stop signal or a pause signal to the motorcontroller to slow down, stop or pause the rotation of the motor(s)which drive the closing of the jaws of the surgical instrument 5500.

Upon changing the closing motion 5526, when the change of the closingmotion 5526 is a slowing down of the closing motion (a slowing down ofthe rotation of the motor(s) which drive the closing of the jaws), theprocess continues 5528 the closing motion originally initiated 5512 butat a reduced speed and the interim process 5514-5522 is continued butthe closing of the jaws occurs at a reduced speed. When the change ofthe closing motion 5526 is a stopping or pausing of the closing motion(a stopping or pausing of the rotation of the motor(s) which drive theclosing of the jaws), the process suspends or terminates 5530 theclosing motion.

FIG. 108 illustrates an example graph 5540 showing a curve 5542representative of a closing force F over time t for various aspects ofthe surgical instrument 5500. The closing force F is shown along thevertical axis and the time t is shown along the horizontal axis. Stateddifferently, the curve 5542 is a graphical representation of the closingforce signal at various times during a closing motion. The curve 5542may be generated mathematically by the controller based on the closingforce signal(s) received by the controller. The closing force Frepresented on the vertical axis may be a force experienced by tissueclamped between the jaws of the surgical instrument 5500, a forceexperienced by the jaws of the surgical instrument 5500 (e.g., by theanvil and/or the elongated channel), a force experienced by the closuretube of the surgical instrument 5500, and/or any combinations thereof.The closing force F can be measured in any suitable manner, eitherdirectly or indirectly. For example, according to various aspects, theclosing force F can be measured directly by a sensor (e.g., a straingauge) positioned on the anvil, on the elongated channel, on the closuretube, or indirectly by an impedance of the tissue, a current draw of themotor, and/or any combinations thereof.

According to various aspects, the operation of the surgical instrument5500 may be controlled by monitoring the amplitude of the closing forcesignal and changing the closing motion when the amplitude of the closingforce signal reaches or exceeds a predetermined threshold. Withreference to FIG. 107, for example, the closing force amplitude Fcritmay be determined to be an excessive amount of the closing force Fexperienced by the surgical instrument 5500. Upon the occurrence of theamplitude of the closing force signal reaching or exceeding the closingforce amplitude Fcrit, an algorithm, such as the method 1010 ofcontrolling a closing motion of the surgical instrument 5500 accordingto various aspects illustrated in FIG. 106, may operate to change theclosing motion by slowing down, pausing or stopping the motor(s) of thesurgical instrument 5500 to prevent the surgical instrument 5500 fromexperiencing excessive forces.

The curve 5542 provides a useful representation of how the closing forceF varies over time t. The change in the closing force F over time t(i.e., the rate of change of the closing force F) may provide usefulfeedback to the control circuit to control the jaw closing mechanism ofthe surgical instrument 5500. The change in the closing force F overtime t may be represented as a derivative of the curve 5542 and may beapproximated over short periods of time by the equation Slope S=ΔF/Δt,where ΔF is the change of the closing force F and Δt is the change ofthe time t. The curve 5542 is representative of an analog signal overtime which is sampled and converted to a digital value by an A/Dconverter as the jaws are closed/opened. Once the analog signal isdigitized, the control circuit may thereafter determine the slope of theclosing force signal represented by the curve 5542 at any point duringthe closing motion.

According to various aspects, the operation of the surgical instrument5500 may be controlled by monitoring the slope of the curve 5542 (theslope of the closing force signal) and changing the closing motion basedon the value of the slope. In general, with reference to FIG. 108, theslope of the curve 5542 may be approximated by the equation S=ΔF/Δt,where ΔF is the change of the closing force F and Δt is the change ofthe time t. Those skilled in the art will appreciate that theinstantaneous slope may be calculated by taking the derivative of thecurve 5542. Over time t, the slope S may be monitored by the controlcircuit and utilized by the control circuit to control the operation ofthe surgical instrument 5500. For example, an algorithm of the surgicalinstrument 5500 may be configured to monitor the change of the closingforce F over the time t, stop or pause the closing motion when the slopeof the curve 5542 reaches or exceeds a first predetermined threshold,then restart the closing motion when the slope of the curve 5542 reachesor falls below a second predetermined threshold. The value of the slopeC=ΔF1/Δt1 (a positive value) shown in FIG. 108 may be determined by thecontroller and may represent the first predetermined threshold.Similarly, the value of the slope D=ΔF2/Δt2 (a negative value) shown inFIG. 108 may be determined by the controller and may represent thesecond predetermined threshold. Thus, according to various aspects, thealgorithm can control the operation of the control circuit based on thedetermined slope, whether instantaneous or approximated.

For the example graph 5540 shown in FIG. 108, at time t=0 the jaws arein the open position and there is no closing force F experienced by thejaws. Once tissue is positioned between the jaws, as the jaws are movedtoward a closed position, the jaws come in contact with tissue and beginto compress the tissue. Thus, as the time moves from the time t=0, theclosing force F experienced by the jaws begins to increase. An algorithmof the surgical instrument 5500 may automatically stop or pause afurther closing of the jaws based on a trigger, a threshold and/or anevent. For example, when the change of the closing force F over time treaches or exceeds a predetermined threshold (e.g., the slope C isgreater than the predetermined threshold), the algorithm mayautomatically stop or pause further closing of the jaws. Alternatively,when the closing force F reaches or exceeds another predeterminedthreshold (e.g., the closing force F is greater than Fcrit), thealgorithm may automatically stop or pause further closing of the jaws.

After the closing of the jaws is stopped or paused, fluid may continueto be displaced from the tissue over time thereby causing the pressureexperienced by the jaws to decrease. The control algorithm mayautomatically re-enable a further closing of the jaws based on atrigger, a threshold or and/or an event. For example, when the change ofthe closing force F over time t reaches or falls below a predeterminedthreshold (e.g., the slope D is more negative than the predeterminedthreshold), the algorithm may automatically restart a further closing ofthe jaws. A portion of the curve 5542 having the slope D may beindicative of a stabilized tissue condition. Alternatively, when apredetermined period of time has passed since the closing of the jawswas stopped or paused (e.g., the time period t1 in FIG. 108), thealgorithm may automatically restart a further closing of the jaws. Thepredetermined period of time may be considered an adequate amount oftime for an adequate amount of tissue creep to occur and/or for thetissue to reach a stabilized condition.

The above-described automatic stopping or pausing and automaticrestarting may be repeated any number of times. As more pressure isapplied to the tissue (i.e., the jaws experience more force), the amountof time which occurs between an automatic stopping or pausing and anautomatic restarting tends to increase (e.g., the time period t3 isgreater than the time period t2 which is greater than the time periodt1). Once the tissue is deemed to be sufficiently compressed, the jawsof the surgical instrument 5500 can be locked into a closed or clampedposition, the closing force F remains essentially constant and thefiring motion can be initiated.

Although the example graph 5540 of FIG. 108 was described in the contextof various aspects of the surgical instrument 5500, it will beappreciated that the respective illustrations and descriptions of theclosing force F can vary for other aspects. For example, in variousaspects of the surgical instrument 5500, fewer than or more than threeautomatic stops or pauses may be required before the tissue is deemed tobe sufficiently compressed. Similarly, fewer than or more than threeautomatic restarts may occur before the tissue is deemed to besufficiently compressed. Also, although FIG. 108 was described in thecontext of the closing force F over time t, it will be appreciated thatin various aspects, a firing force (not shown) may also bemeasured/sampled over time. As described in more detail hereinbelow, thefiring force measurements and parameters related thereto may be utilizedby the control circuit to automatically change a firing motion based ona trigger, a threshold and/or an event.

FIG. 109 illustrates an example graph 5550 showing a curve 5552representative of a firing force F over time t for various aspects ofthe surgical instrument 5500 and a curve 5554 representative of a knifevelocity V over time t for various aspects of the surgical instrument5500. The firing force F is shown along an upper portion of the verticalaxis, the knife velocity V is shown along a lower portion of thevertical axis and the time t is shown along the upper horizontal axis aswell as along the lower horizontal axis. Stated differently, the curve5552 is a representation of the firing force signal at various timesduring a firing motion and the curve 5554 is a representation of theknife velocity signal at various times during a firing motion. As shownin FIG. 109, the knife transitions over three distinct zones Z1, Z2, Z3.In zone Z1, the knife velocity V and force F are ramping up from a zeroinitial value. In zone Z2, the knife is traveling at a relativelyconstant velocity V and spikes in the measured force F are due to thestaple driving force. In zone Z3, the knife velocity V and the force Fare ramping down to zero.

The curves 5552, 5554 may be generated mathematically by the controllerbased on the firing force signal(s) and the knife velocity signal(s)received by the controller. The firing force F and the knife velocity Vshown in the example graph 5550 of FIG. 109 may be representative of acondition where the thickness and composition of the tissue along thecut line is uniform. The firing force F represented on the upper portionof the vertical axis may be a force experienced by the drive system ofthe surgical instrument (e.g., by the sled, the knife and/or the firingbar), and/or any combination thereof. The firing force F can be measuredin any suitable manner, either directly or indirectly. For example,according to various aspects, the firing force F can be measureddirectly by a sensor (e.g. a strain gauge) positioned on the sled, onthe knife, or indirectly by a current draw of the motor, and/or anycombination thereof. The knife velocity V represented on the lowerportion of the vertical axis may be a velocity of the knife, a velocityof the sled, a velocity of another component of the drive system (e.g.,the firing bar), and/or any combination thereof. The knife velocity Vcan be measured in any suitable manner, either directly or indirectly.For example, according to various aspects, the knife velocity V can bemeasured directly by a combination of a magnet positioned on the firingbar and a Hall-effect sensor or indirectly by a current draw of themotor, an encoder coupled to the shaft of the motor, and/or anycombination thereof.

As explained in more detail hereinbelow (See, e.g., FIG. 110), invarious aspects the surgical instrument 5500 can measure and/ordetermine the following: an instantaneous firing force F, one or morepeak values of the firing force F, one or more valley values of thefiring force F, an average of the firing force F, a change of the firingforce F over time t (i.e., a rate of change of the firing force F), aslope of a line connecting successive peak values of the firing force F,a slope of a line connecting successive valley values of the firingforce F, a time between successive peak values of the firing force F, atime between successive valley values of the firing force F, a decreaseof the firing force F from a peak value of the firing force F to afollowing valley value of the firing force F, an increase of the firingforce F from a valley value of the firing force F to a following peakvalue of the firing force F, an instantaneous knife velocity V, one ormore peak values of the knife velocity V, one or more valley values ofknife velocity V, an average of the knife velocity V, a change of theknife velocity V over time t (i.e., a rate of change of the knifevelocity V), and/or any combinations thereof.

For the example graph 5550 shown in FIG. 109, at time t=0 the firingforce F is essentially zero, the knife is in the fully retractedposition and the knife is stationary (the knife velocity V is zero).Once the firing motion is actuated, the knife begins to advance andinitially advances at an increasing velocity. As the knife advances, thesled advances and the staples are driven from the staple cartridge,through the tissue and against the anvil. As the knife and sled advanceand the knife velocity V increases, the firing force F increases andreaches a first peak value when a first row of staples is driven fromthe staple cartridge. At this point in time, the knife is not yet incontact with the tissue. For the example graph 5550 shown in FIG. 109,the first peak 5556 of the firing force F is indicative of the first rowof staples being driven from the staple cartridge. According to variousaspects, the first row of staples is not driven through the tissue andis thus not driven against the anvil. According to other aspects, thefirst row of staples is driven through a portion of the tissue which isthinner than the thickest portion of the tissue and against the anvil.According to yet other aspects, the first row of staples is driventhrough a portion of the tissue which was previously stapled (withstaples from another staple cartridge), thereby resulting in thatportion of the tissue being double stapled.

After the first row of staples is driven as described hereinabove, thefiring force F decreases until a second row of staples is driven, whichcauses the firing force F to reach a second peak 5558. At this point intime, the knife is not yet in contact with the tissue. For the examplegraph 5550 shown in FIG. 109, the second peak 5558 is indicative of thesecond row of staples being driven from the staple cartridge. Accordingto various aspects, the second row of staples is not driven through thetissue and is thus not driven against the anvil. According to otheraspects, the second row of staples is driven through a portion of thetissue which is thicker than the portion of tissue through which thefirst row staples was driven (but thinner than the thickest portion ofthe tissue) and against the anvil. According to yet other aspects, thesecond row of staples is driven through a portion of the tissue whichwas already stapled (with staples from another staple cartridge),thereby resulting in that portion of the tissue being double stapled.

After the second row of staples is driven as described hereinabove, thefiring force F decreases until a third row of staples is driven, whichcauses the firing force F to reach a third peak 5560. At this point intime, the knife is not yet in contact with the tissue. For the examplegraph 5550 shown in FIG. 109, the third peak 5560 is indicative of thethird row of staples being driven from the staple cartridge. Accordingto various aspects, the third row of staples is not driven through thetissue and is thus not driven against the anvil. According to otheraspects, the third row of staples is driven through a portion of thetissue which is thicker than the portion of tissue through which thesecond row staples was driven (but thinner than the thickest portion ofthe tissue) and against the anvil. According to yet other aspects, thethird row of staples is driven through a portion of the tissue which wasalready stapled (with staples from another staple cartridge), therebyresulting in that portion of the tissue being double stapled.

After the third row of staples is driven as described hereinabove, thefiring force F decreases until a fourth row of staples is driven, whichcauses the firing force F to reach a fourth peak 5562. At some pointafter the third row of staples is driven, the knife comes into contactwith the tissue, begins severing the tissue and advances at asubstantially constant velocity. For the example graph 5550 shown inFIG. 109, the fourth peak 5562 is indicative of the knife severing thetissue and the fourth row of staples being driven from the staplecartridge through the tissue and against the anvil.

After the fourth row of staples is driven as described hereinabove, thefiring force F continues the cycle of decreasing and increasing as theknife advances through the tissue at a substantially constant velocityand additional rows of staples are driven through the tissue and againstthe anvil. For the aspects shown in FIG. 109, the knife velocity V issubstantially constant from the time the knife comes in contact with thetissue (shortly before the fourth peak value of the firing force isreached) to a time shortly after the knife has severed through thetissue (the last peak value before the last three rows of staples aredriven). Shortly after the knife has severed through the tissue, theknife velocity V begins to decrease from the substantially constantvelocity to zero. The decrease in the knife velocity V and the lowerforces required to drive the last three rows of staples produces lowerand lower peak values of the firing force F. There are a number ofdifferent reasons why lower forces are required to drive the last threerows of staples. For example, according to various aspects, the lastthree rows of staples may extend past the tissue (and thus are notdriven through the tissue and against the anvil), the last three rows ofstaples may be driven through a less compressed portion of the tissue(due to the geometry of the anvil and the elongated channel), the lastthree rows of staples may be driven through a thinner portion of thetissue, and/or any combination thereof. Once all of the staples havebeen driven and the knife velocity V has reached zero (the knife hasstopped advancing), the firing force F is zero.

Although the example graph 5550 of FIG. 109 was described in the contextof various aspects of the surgical instrument 5500, it will beappreciated that the respective illustrations and descriptions of thefiring force F and the knife velocity V can vary for other aspects. Forexample, in various aspects of the surgical instrument 5500, the knifemay come into contact with the tissue after fewer than or more thanthree rows of staples have been driven from the staple cartridge.Similarly, fewer than or more than three rows of staples may be drivenafter the knife has severed through the tissue.

FIG. 110 illustrates an example graph 5570 showing a curve 5572representative of a firing force F and a knife position X over time tfor various aspects of the surgical instrument 5500. The firing force Fis shown along the vertical axis and the knife position X and the time tare shown along the horizontal axis. As shown along the horizontal axis,the knife position X travels over five Zones 1-5 along the knife channelin the cartridge 304 located in the lower jaw 302 of the end effector300 of the surgical instrument 5500, as described in more detailhereinbelow. In summary, Zone 1 is a tissue free zone where the knifemoves without contacting tissue until it initially contacts tissue inZone 2. The knife then transects the tissue as it travels along Zone 3.The knife transitions out of the tissue in Zone 4 and in stops in Zone5, where the knife reaches the end of its travel span in a tissue freeregion. The spikes 5574 in the various sections 1-5 are due theadditional force required to drive staples through the tissue located inthe jaws 306, 302 of the end effector 300 portion of the surgicalinstrument 5500.

Accordingly, the curve 5572 is a representation of the firing forcesignal at various times during a firing motion in combination with thestaple driving force, collectively referred to herein a the drivingforce F. The curve 5572 may be generated mathematically by thecontroller based on the firing force signal(s) received by thecontroller. The firing force F and the knife position X force shown inthe example graph 5570 may be representative of a condition where thethickness and composition of the tissue along the cut line is uniform.The firing force F represented on the vertical axis may be a forceexperienced by the drive system of the surgical instrument 5500 (e.g.,by the sled, the knife, and/or the firing bar), and/or any combinationthereof. The firing force F can be measured in any suitable manner,either directly or indirectly. For example, according to variousaspects, the firing force F can be measured directly by a sensor (e.g.,a strain gauge) positioned on the sled, on the knife, or indirectly by acurrent draw of the motor, and/or any combination thereof.

According to various aspects, the operation of the surgical instrument5500 may be controlled by monitoring the amplitude of the firing forcesignal and the knife position X, and changing the firing motion when theamplitude of the firing force signal reaches or exceeds a predeterminedthreshold. As previously described, this process may be controlled withan algorithm such as the method 1010 of controlling a closing motion ofthe surgical instrument 5500 according to various aspects illustrated inFIG. 107. According to some aspects, the changing of the firing motiononly proceeds when the knife position is within a predetermined range ofpositions. With reference to FIG. 110, for example, firing forceamplitude Fcrit may be determined to be an excessive amount of thefiring force F experienced by the surgical instrument 5500. Upon theoccurrence of the amplitude of the firing force signal reaching orexceeding the firing force amplitude Fcrit, an algorithm may operate tochange the firing motion by slowing down, pausing or stopping therotation of the motor(s) which drive the knife of the surgicalinstrument 5500 to prevent the surgical instrument 5500 fromexperiencing excessive forces.

The curve 5572 provides a useful representation of how the firing forceF and the knife position X vary over time t. The change in the firingforce F over time t (i.e., the rate of change of the closing force F)may provide useful feedback to the control circuit to control the firingmechanism of the surgical instrument 5500. The change in the firingforce F over time t may be represented as a derivative of the curve 5572and may be approximated over short periods of time by the equation SlopeS=ΔF/Δt, where ΔF is the change of the firing force F and Δt is thechange of the time t. The slope can have a positive value or a negativevalue. The slope represented by ΔF1/Δt1 of the curve 5572 has a positivevalue and the slope represented by

ΔF2/Δt2 of the curve 5572 has a negative value. The curve 5572 isrepresentative of an analog signal over time which is sampled andconverted to a digital value by an A/D converter as the firing mechanismis advanced/retracted. Once the analog signal is digitized, the controlcircuit may thereafter determine the slope of the firing force signalrepresented by the curve 5542 at any point during the firing motion.

According to various aspects, the operation of the surgical instrument5500 may be controlled by monitoring the slope of the curve 5572 (theslope of the firing force signal) and the knife position X, and changingthe firing motion based on the value of the slope. According to someaspects, the changing of the firing motion only proceeds when the knifeposition is within a predetermined range of positions. In general, withreference to FIG. 110, the slope of the curve 5572 may be approximatedby the equation S=ΔF/Δt, where ΔF is the change of the firing force Fand At is the change of the time t. Those skilled in the art willappreciate that the instantaneous slope may be calculated by taking thederivative of the curve 5572. Over time t, the slope S may be monitoredby the control circuit and utilized by the control circuit to controlthe operation of the surgical instrument 5500. For example, an algorithmof the surgical instrument 5500 may be configured to monitor the changeof the firing force F over the time t, stop or pause the firing motionwhen the slope of the curve 5572 reaches or exceeds a firstpredetermined threshold, then restart the firing motion when the slopeof the curve 5572 reaches or falls below a second predeterminedthreshold. The value of the slope represented by ΔF1/Δt1 (a positivevalue) shown in FIG. 110 may be determined by the controller and mayrepresent the first predetermined threshold. Similarly, the value of theslope represented by ΔF2/Δt2 (a negative value) shown in FIG. 110 may bedetermined by the controller and may represent the second predeterminedthreshold. Thus, according to various aspects, the algorithm can controlthe operation of the control circuit based on the determined slope,whether instantaneous or approximated.

According to various aspects, the operation of the surgical instrument5500 may be controlled by monitoring a parameter related to the firingforce signal and the knife position X, and changing the firing motionbased on the value of the parameter. According to some aspects, thechanging of the firing motion only proceeds when the knife position iswithin a predetermined range of positions. With reference to FIG. 110,for example, an algorithm of the surgical instrument 5500 may beconfigured to monitor first and second parameters (e.g., the slope of aline connecting successive peak values of the firing force signalrepresented by ΔF3/Δt3 and the slope of a line connecting successivevalley values of the firing force signal represented by ΔF4/Δt4 in FIG.110), stop or pause the firing motion when the value of the firstparameter reaches or exceeds a first predetermined threshold, thenrestart the firing motion when the value of the second parameter reachesor falls below a second predetermined threshold. The value of the sloperepresented by ΔF3/Δt3 (a positive value) shown in FIG. 110 may bedetermined by the controller and may represent the first predeterminedthreshold. Similarly, the value of the slope represented by ΔF4/Δt4 (anegative value) shown in FIG. 110 may be determined by the controllerand may represent the second predetermined threshold. Thus, according tovarious aspects, the algorithm, such as the method 1010 of controlling aclosing motion of the surgical instrument 5500 according to variousaspects shown in FIG. 107, can control the operation of the controlcircuit based on the determined slopes, whether instantaneous orapproximated.

Alternatively, the controller may determine values for other parametersrelated to the firing force signal and utilize the values of theparameters to change the firing motion. According to some aspects, thechanging of the firing motion only proceeds when the knife position iswithin a predetermined range of positions. With regard to FIG. 110, theother parameters may include, for example, a duration between successivepeak values of the firing force signal represented by the time period Ashown in FIG. 110, a duration between successive valley values of thefiring force signal represented by the time period B shown in FIG. 110,a decrease in the amplitude of the firing force signal from a peak valueto a following valley value as represented by the magnitude C shown inFIG. 110 and an increase in the firing force signal from a valley valueto a following peak value represented by the magnitude D shown in FIG.110. The above-described parameters/values determined by the controlcircuit can be utilized with or without the knife position X toautomatically control the firing motion of the surgical instrument 5500.Additionally, the above-described parameters/values determined by thecontrol circuit can be utilized within a limited time/rate window incombination with surgeon variable rate actuation control and feedback.

For the example graph 5570 shown in FIG. 110, at time t=0 the knife isin a fully retracted position near the proximal end of the end effectorand over time advances to a fully advanced position near the distal endof the end effector. The overall distance the knife moves from the fullyretracted position to the fully advanced position during a firing motioncan be divided into predefined zones, with each predefined zonerepresentative of a different operating condition of the surgicalinstrument 5500. For example, according to various aspects, the overalldistance the knife moves from the fully retracted position to the fullyadvanced position during a firing motion can be divided into fivepredefined zones and the five zones may be representative of thefollowing: Zone 1 is representative of the knife advancing from a fullyretracted position at an increasing velocity but not yet being incontact with tissue positioned between the jaws of the surgicalinstrument; Zone 2 is representative of the knife advancing at a morerapidly increasing velocity and staples being driven into the tissue(but not into the thickest portion of the tissue); Zone 3 isrepresentative of the knife reaching a maximum or peak velocity, thencontinuing to advance at a substantially constant velocity and staplesbeing driven into the thickest portion of the tissue; Zone 4 isrepresentative of the knife continuing to advance at a substantialconstant velocity, then decreasing in velocity after the tissue has beensevered and staples still being driven into the thickest portion of thetissue; and Zone 5 is representative of the knife having reached itsfully advanced position (the knife has stopped) and all of the stapleshave been fired.

Although five zones are shown in FIG. 110, it will be appreciated thatthe overall distance the knife moves from the fully retracted positionto the fully advanced position during a firing motion can be dividedinto more than or less than five zones, and the respective zones can berepresentative of operating conditions different from those describedhereinabove.

In practice, the thickness and composition of the tissue can vary alongthe cut line. Thus, it will be appreciated that there are manyconditions which can cause the firing force F, the knife velocity Vand/or the knife position X to deviate from the firing force F, theknife velocity V and/or the knife position X shown in FIGS. 103 and 104.

FIG. 111 illustrates an example graph 5580 showing a curve 5582representative of a firing force F over time t for various aspects ofthe surgical instrument 5500 and a curve 5584 representative of a knifevelocity V over time t for various aspects of the surgical instrument5500. Stated differently, the curve 5582 is a representation of thefiring force signal at various times during a firing motion and thecurve 5584 is a representation of the knife velocity signal at varioustimes during a firing motion. The curves 5582, 5584 may be generatedmathematically by the controller based on the firing force signal(s) andthe knife velocity signal(s) received by the controller. The firingforce F is shown along an upper portion of the vertical axis, the knifevelocity V is shown along a lower portion of the vertical axis and thetime t is shown along the upper horizontal axis as well as along thelower horizontal axis. The firing force F represented on the upperportion of the vertical axis may be a force experienced by the drivesystem of the surgical instrument 5500 (e.g., by the sled, the knifeand/or the firing bar), and/or any combination thereof. The firing forceF can be measured in any suitable manner, either directly or indirectly.For example, according to various aspects, the firing force F can bemeasured directly by a sensor (e.g., a strain gauge) positioned on thesled, on the knife, or indirectly by a current draw of the motor, and/orany combination thereof.

The knife velocity V represented on the lower portion of the verticalaxis may be a velocity of the knife, a velocity of the sled, a velocityof another component of the drive system (e.g., the firing bar), and/orany combination thereof. The knife velocity V can be measured in anysuitable manner, either directly or indirectly. For example, accordingto various aspects, the knife velocity V can be measured directly by acombination of a magnet positioned on the firing bar and a Hall-effectsensor or indirectly by a current draw of the motor, an encoder coupledto the shaft of the motor, and/or any combination thereof.

In addition to the firing force F and the knife velocity V beingmeasured, the firing force measurements (including the parameters/valuesderived therefrom) and the knife velocity measurements can be stored bya memory of the surgical instrument 5500. An algorithm of the controlcircuit of the surgical instrument 5500 can utilize the storedmeasurements to provide automated control of the surgical instrument5500. For example, according to various aspects, the algorithm canautomatically stop or pause a further advancement of the knife based ona trigger, a threshold and/or an event. For example, when a slope of aline connecting successive peak values of the firing force signal (e.g.,the slope of the line A shown in FIG. 111) reaches or exceeds apredetermined threshold (e.g., the slope of the line A is greater thanthe predetermined threshold), the algorithm can automatically stop orpause a further advancement of the knife.

According to other aspects, the algorithm can automatically stop orpause a further advancement of the knife when a slope of a lineconnecting successive peak values of the firing force signal and theamplitude of the firing force signal reaches or exceeds a secondpredetermined threshold (e.g., the amplitude is greater than the firingforce amplitude F1). According to yet other aspects, the algorithm canautomatically stop or pause a further advancement of the knife when thea slope of a line connecting successive peak values of the firing forcesignal reaches or exceeds a predetermined threshold, the amplitude ofthe firing force signal reaches or exceeds a second predeterminedthreshold and the position of the knife is within a predefined zone ofoperation (e.g., a position where the knife is advancing at asubstantially constant velocity). For these aspects, when thecombinations are met, the controller signals the motor controller tochange the firing motion by slowing down, pausing or stopping therotation of the motor(s) which drive the knife of the surgicalinstrument 5500 to prevent the surgical instrument 5500 fromexperiencing excessive forces. For the example graph 5580 shown in FIG.111, when the combinations are met, the controller communicates a pausesignal or a stop signal to the motor controller to change the firingmotion by pausing or stopping the rotation of the motor(s) which drivethe knife velocity and the knife velocity is reduced from thesubstantially constant velocity to zero.

After the advancement of the knife has been stopped or paused, thealgorithm may automatically restart the advancement of the knife basedon a trigger, a threshold and/or an event. For example, according tovarious aspects, the algorithm can automatically restart the advancementof the knife when a slope of the curve 5582 (e.g., the slope ΔF/Δt shownin FIG. 111) reaches or falls below a predetermined threshold. Thepredetermined threshold may be indicative of a stabilized tissuecondition. According to other aspects, when a predetermined period oftime has passed since the advancement of the knife was stopped or paused(e.g., the period of time between t1 and t2 in FIG. 111), the algorithmmay automatically restart a further advancement of the knife. Thepredetermined period of time may be considered an adequate amount oftime for an adequate amount of tissue creep to occur and/or for thetissue to reach a stabilized condition.

According to yet other aspects, when the amplitude of the firing forcesignal drops a predetermined amount from what the amplitude of thefiring force signal was at the time of the initiation of the stop orpause, the algorithm may automatically restart a further advancement ofthe knife. The predetermined amount of the drop in the amplitude of thefiring force signal may be a quantitative amount (e.g., the differencebetween the firing force amplitude F1 and the firing force amplitude F2in FIG. 111) or a percentage (e.g., a 10% drop). The predeterminedamount of the drop in firing force signal may be considered sufficientenough for an adequate amount of tissue creep to have occurred and/orfor the tissue to have reached a stabilized condition.

According to yet other aspects, when the amplitude of the firing forcesignal drops to a predetermined value (e.g., the firing force amplitudeF2 shown in FIG. 111), the algorithm may automatically restart a furtheradvancement of the knife. The predetermined value of the firing force Fmay be considered low enough for an adequate amount of tissue creep tohave occurred and/or for the tissue to have reached a stabilizedcondition. Regardless of what the restarting of the knife is based on,when the trigger, threshold and/or event occurs, the controllercommunicates a start signal to the motor controller to restart thefiring motion by restarting the rotation of the motor(s) which drive theknife of the surgical instrument 5500, and the restarting of therotation of the motor(s) causes the knife velocity V to increase fromzero to a substantially constant velocity.

After the knife has severed through the tissue, the knife velocity Vbegins to decrease from the substantially constant velocity to zero. Thedecrease in the knife velocity V and the lower firing force F requiredto drive the last few rows of staples produces lower and lower peakvalues of the firing force signal. Once all of the staples have beendriven and the knife velocity V has reached zero (the knife has stoppedadvancing), the firing force F is zero.

Although the knife position X is not shown in FIG. 111, it will beappreciated that according to some aspects the changing of the firingmotion only proceeds when the knife position is within a predeterminedrange of positions.

FIG. 112 illustrates an example graph 5690 showing a curve 5692representative of a closing force FC over time t for various aspects ofthe surgical instrument 5500 and a curve 5694 representative of a firingforce FF over time t for various aspects of the surgical instrument5500. The closing force FC is shown along the “left” vertical axis, thefiring force FF is shown along the “right” vertical axis and the time tis shown along the horizontal axis. When viewed together the curves5692, 5694 reflect the timing of the closing motion and the firingmotion relative to one another, where the closing motion is initiatedprior to the initiation of the firing motion. Although the example graph5690 shows a threshold force Fcrit as being the same amplitude for boththe closing force FC and the firing force FF, it will be appreciatedthat the amplitude of the threshold force Fcrit for the closing force FCmay be different from the amplitude of the threshold force Fcrit for thefiring force FF. Stated differently, the scale of the “left” verticalaxis can be different from the scale of the “right” vertical axis.

The curve 5692 is a graphical representation of the closing force signalat various times during a closing motion and may be similar or identicalto the curve 5542 of FOG. 108. Thus, as set forth hereinabove, the curve5692 may be generated mathematically by the controller based on theclosing force signal(s) received by the controller. The closing force FCrepresented on the “left” vertical axis may be a force experienced bytissue clamped between the jaws of the surgical instrument 5500, a forceexperienced by the jaws of the surgical instrument 5500 (e.g., by theanvil and/or the elongated channel), a force experienced by the closuretube of the surgical instrument 5500, and/or any combinations thereof.The closing force FC can be measured in any suitable manner, eitherdirectly or indirectly. For example, according to various aspects, theclosing force FC can be measured directly by a sensor (e.g., a straingauge) positioned on the anvil, on the elongated channel, on the closuretube, or indirectly by an impedance of the tissue, a current draw of themotor, and/or any combinations thereof.

The curve 5694 is a graphical representation of the firing force signalat various times during a firing motion. The curve 5694 may be generatedmathematically by the controller based on the firing force signal(s)received by the controller. The firing force FF represented on the“right” vertical axis may be a force experienced by the drive system ofthe surgical instrument 5500 (e.g., by the sled, the knife, and/or thefiring bar), and/or any combination thereof. The firing force FF can bemeasured in any suitable manner, either directly or indirectly. Forexample, according to various aspects, the firing force FF can bemeasured directly by a sensor (e.g., a strain gauge) positioned on thesled, on the knife, or indirectly by a current draw of the motor, and/orany combination thereof. Although not shown for purposes of simplicity,the respective zones of the firing cycle (e.g., zones 1-5 as describedhereinabove) could also be shown along the horizontal axis.

For the example graph 5690 in FIG. 112, at some time after the closingmotion has commenced, the knife is still in the fully-retracted positionand the firing force FF is approximately zero. As the knife and sledadvance and the velocity of the knife increases, the firing force FFincreases and reaches a first peak value 5696 when a first row ofstaples is driven from the staple cartridge. After the first row ofstaples is driven as described hereinabove, the firing force FFdecreases until a second row of staples is driven, which causes thefiring force FF to reach a second peak value 5698.

At a later point in the firing motion, the slope of the firing forcesignal reaches or exceeds a predetermined threshold (this condition isshown as the slope A of the firing force signal in FIG. 112) and theamplitude of the firing force FF reaches or exceeds a predeterminedamplitude threshold (e.g., the amplitude Fcrit shown in FIG. 112). Inresponse, the control algorithm acts to slow down, stop or pause thefurther advancement of the knife and the firing force FF begins todecrease.

For the example graph 5690, the slowing down, stopping or pausing of theknife continues until the firing force FF reaches a value which is 10%less than the predetermined amplitude threshold (e.g., Fcrit), at whichpoint the further advancement of the knife is commenced. Of course,according to various aspects, the further advancement of the knife canbe commenced when the firing force FF reaches a value which is less thanor more than the 10% example shown in FIG. 112. The above-describedautomatic stopping or pausing and automatic restarting may be repeatedany number of times. For the example graph 5690, once the furtheradvancement of the knife is commenced, the knife advances towards itsfully advanced position and the firing force FF eventually decreases tozero as indicated at the far right side.

FIGS. 113, 114 illustrate various aspects of a direction sensor 5590 ofthe surgical instrument 5500. According to various aspects, the controlcircuit of the surgical instrument 5500 may be configured to stop anadvancement of the knife when a staple cartridge is not positioned orproperly positioned in the elongated channel. For such aspects, thecontrol circuit may include the direction sensor 5590, a main processorand a safety processor, each positioned in the shaft assembly, asdescribed above in connection with FIGS. 16A-17B. The direction sensor5590 is electrically connected to the main processor and/or the safetyprocessor of the shaft assembly. The main processor and/or the safetyprocessor of the shaft assembly may be electrically connected to themain processor and/or the safety processor of the handle assembly. Thedirection sensor 5590 is positioned at a location relative to a startingpoint of the tissue transection, and is configured to sense movement ofthe firing bar and output a signal (e.g., a voltage) related to thesensed position of the firing bar to the main processor and/or safetyprocessor of the shaft assembly. Based on the sensed movement of thefiring bar, the main processor and/or the safety processor of the shaftassembly can determine and track a status of the movement and thedirection of the movement of the firing bar as the firing bar movesdistally and proximally of the starting point of the tissue transection.The main processor and/or the safety processor of the shaft assembly cansignal the motor controller to power, cycle and/or reboot the electricmotor to control the movement and the direction of the movement of thefiring bar, and thus the movement and the direction of the movement ofthe knife, all while continuing to determine the relevant position ofthe firing bar based on the output signal of the direction sensor 5590.

As shown in FIGS. 113, 114, the direction sensor 5590 includes first andsecond sensors 5592, 5594, first and second transistors 5596, 5598, anoperational amplifier 5600 and a resistive element 5602. The first andsecond sensors 5592, 5594 may be Hall-effect sensors, with each of thefirst and second Hall-effect sensors being positioned a set distancefrom the tissue transection or cut line. Collectively, the first andsecond transistors 5596, 5598, the operational amplifier 5600 and theresistive element 5602 comprise a latching circuit, where the latchingcircuit outputs only the voltage related to the last Hall-effect sensorthat was activated.

FIG. 113 indicates a firing stroke in which the magnet 5604 moves froman initial proximal position to a distal position. In FIG. 113, themagnet 5604 is shown in the final distal position and the output of theoperational amplifier 5600 indicates the distal position of the magnet5604. In operation, as the firing bar moves distally from a proximalstarting point of the tissue transection as shown in FIG. 113, a magnet5604 positioned on the firing bar moves past the first Hall-effectsensor 5594 then past the second Hall-effect sensor 5592. As the magnet5604 moves past the first Hall-effect sensor 5594, the first Hall-effectsensor 5594 outputs a signal which is indicative of the movement of thefiring bar to a gate of the first transistor 5598 to drive the latchingcircuit to a first stable state Vcc. As the magnet 5604 moves past thesecond Hall-effect sensor 5592, the second Hall-effect sensor 5592outputs a signal which is indicative of the movement of the firing barto a gate of the second transistor 5596 to drive the latching circuit toa second stable state 0.0 V. The latching circuit outputs a signal(e.g., a voltage 0.0 V) indicative of the second stable state to themain processor and/or the safety processor of the shaft assemblyindicating that the firing bar is in the distal fired position.

FIG. 114 indicates a retracting stroke in which the magnet 5604 movesfrom an initial distal position to a final proximal position. In FIG.114, the magnet 5604 is shown in the final proximal position and theoutput of the operational amplifier 5600 indicates the proximal positionof the magnet 5604. In operation, as the firing bar moves proximallytoward the starting point of the tissue transection as shown in FIG.114, the magnet 5604 positioned on the firing bar moves past the secondHall-effect sensor 5592 then past the first Hall-effect sensor 5594. Asthe magnet 5604 moves past the second Hall-effect sensor 5592, thesecond Hall-effect sensor 5592 outputs a signal which is indicative ofthe movement of the firing bar to the gate of the second transistor 5596to drive the latching circuit to the second stable state of 0.0 V. Asthe magnet 5604 moves past the first Hall-effect sensor 5594, the firstHall-effect sensor 5594 outputs a signal which is indicative of themovement of the firing bar to the gate of the first transistor 5598 todrive the latching circuit to the first stable state Vcc. The latchingcircuit outputs a signal (e.g., a voltage of Vcc) indicative of thefirst stable state to the main processor and/or the safety processor ofthe shaft assembly indicating that the firing bar is in the proximalretracted position.

FIG. 115 illustrates a perspective view of a surgical instrument 5700 inaccordance with one or more aspects described herein. The surgicalinstrument 5700 is similar to the surgical instrument 5500 and includesan elongated channel configured to support a staple cartridge, an anvilpivotably connected to the elongated channel, a closure membermechanically coupled to the anvil, a knife mechanically coupled to thestaple cartridge, an electric motor mechanically coupled to the closuremember and/or the knife, a motor controller electrically coupled to themotor, and a control circuit electrically coupled to the motorcontroller. The surgical instrument 5700 is also similar to the surgicalinstrument 5500 in that the surgical instrument 5700 also includessensors which are collectively configured to sense or measure a closingforce, a firing force, a current drawn by the electric motor, animpedance of tissue positioned between the elongated channel and theanvil, a position of the anvil relative to the elongated channel, aposition of the knife, or any combination thereof. The surgicalinstrument 5700 is also similar to the surgical instrument 5500 in thatthe surgical instrument 5700 also includes algorithms such as closingalgorithms, firing algorithms, motor control algorithms, or anycombination thereof, which operate to dynamically adjust the operationof the surgical instrument 5700. However, the surgical instrument 5700is different from the surgical instrument 5500 in that the surgicalinstrument 5700 further includes one or more additional algorithms (inaddition to those described hereinabove) which provide additionalcontrol functionality for the surgical instrument 5700, as describedhereinbelow.

In certain situations, it may be desirable for the surgical instrument5700 to ignore the occurrence of one or more of the above-describedtriggers, thresholds and/or events associated with the firing force. Inaccordance with one or more aspects, the surgical instrument 5700includes one or more control algorithms which are configured to ignorecertain triggers, thresholds and/or events if the triggers, thresholdsand/or events occur before an amplitude of the firing force has reachedor exceeded a predetermined threshold, if the triggers, thresholdsand/or events occur within certain zones of the firing motion, andcombinations thereof. As described hereinabove, the zones of the firingmotion are related to the position of the knife. In other words, thecontrol algorithms can vary the firing force triggers, thresholds and/orevents (e.g., values of the thresholds) based on the position of theknife within the firing motion.

FIG. 116 illustrates a method 5710 of controlling a firing motion of thesurgical instrument 5700 in accordance with one or more aspects. Theprocess starts when a firing motion is initiated 5712. The closingmotion may be initiated, for example, by pulling a firing trigger towarda handle. A sensor resident with the surgical instrument 5700senses/measures 5714 a firing force. The firing force may be, forexample, a force experienced by the drive system of the surgicalinstrument (e.g., by the sled, the knife and/or the firing bar), and/orany combination thereof. The firing force F can be measured in anysuitable manner, either directly or indirectly. For example, inaccordance with one or more aspects, the firing force F can be measureddirectly by a sensor (e.g. a strain gauge) positioned on the sled, onthe knife, or indirectly by a current draw of the motor.

In response to the firing force, the sensor outputs 5716 a firing forcesignal, which is indicative of the firing force sensed/measured 5714 bythe sensor. Depending on the configuration of the sensor, the firingforce signal can be an analog signal or a digital signal. Upondetermining 5718 whether the firing force signal is either an analogsignal or a digital signal, the process proceeds along the correspondingbranch. When the determination 5718 is that the firing force signal isan analog signal, the process proceeds along the analog branch, wherethe analog signal is received by an A/D converter, converted 5720 to adigital signal representative of the analog signal by the A/D converterand the digital signal is output by the A/D converter. When thedetermination 5718 is that the firing force signal is a digital signal,the process proceeds along the digital branch because there is no needfor an A/D conversion 5720 when the firing force signal is a digitalsignal.

The firing force signal which is a digital signal representative of thefiring force sensed/measured 5714 by the sensor is received by acontroller. The controller utilizes the digital signal and determines5722 whether the firing force sensed/measured 5714 by the sensor reachesor exceeds a predetermined threshold. The controller may make thisdetermination 5722 based on a comparison of a magnitude of the firingforce sensed/measured 5714 by the sensor and the predeterminedthreshold, based on a comparison of an amplitude of the firing forcesignal output 5716 by the sensor and a predetermined threshold, or anycombination thereof.

When the controller determines 5722 that the firing forcesensed/measured 5714 by the sensor has not reached or exceeded thepredetermined threshold, the firing motion originally initiated 5712 iscontinued 5724 along with interim processes 5714-5722. When thecontroller determines 5722 that the firing force sensed/measured 5714 bythe sensor has reached or exceeded the predetermined threshold, thecontroller then determines 5726 whether or not to ignore the fact thatthe firing force has reached or exceeded the predetermined threshold.This determination 5726 can be based, for example, on whether or not theamplitude of the firing force signal has reached or exceeded apredetermined threshold, based on the position of the sled, the knifeand/or the firing bar, or any combinations thereof. For example, asdescribed in more detail hereinbelow, in certain aspects the controllermay determine 5726 to ignore the fact that the slope of the firing forcesignal has reached or exceeded a predetermined slope threshold if theamplitude of the firing force signal has not yet reached or exceeded apredetermined amplitude threshold. In other aspects, the controller maydetermine 5726 to ignore the fact that the slope of the firing forcesignal has reached or exceeded a predetermined slope threshold based onthe position of the sled, the knife, the firing bar, or any combinationthereof when the knife is in a certain zone (e.g., Zone 1 or Zone 5) ofthe firing motion. For instances when the controller determines 5726 toignore the fact that a parameter of the firing force signal has reachedor exceeded a predetermined threshold, the firing motion originallyinitiated 5712 is continued 5724 along with interim processes 5714-5722.

In other aspects, the controller may determine 5726 not to ignore thefact that a parameter of the firing force signal has reached or exceededa predetermined threshold. The determination 5726 not to ignore the factthat a parameter of the firing force signal has reached or exceeded thepredetermined threshold can be based, for example, on whether or not theamplitude of the firing force signal has reached or exceeded apredetermined threshold, based on the position of the sled, the knifeand/or the firing bar, or any combinations thereof. For instances whenthe controller determines 5726 not to ignore the fact that a parameterof the firing force signal has reached or exceeded the predeterminedthreshold the controller changes 5730 the firing motion. According tosome aspects, the controller may change the firing motion by modifyingor adjusting a firing algorithm being executed by the controller tocause the firing motion to be slowed down, paused or stopped to preventthe surgical instrument 5700 from experiencing excessive forces.According to other aspects, the controller may change the firing motionby executing a different firing algorithm which causes the firing motionto be slowed down, paused or stopped to prevent the surgical instrument5700 from experiencing excessive forces. In either case, the firingmotion may be slowed down, stopped or paused by having the controllercommunicate a slow down signal, a stop signal or a pause signal to themotor controller to slow down, stop or pause the rotation of themotor(s) which drive the sled, knife, firing bar or any combinationthereof of the surgical instrument 5700.

Upon changing the firing motion 5728, when the change of the firingmotion 5728 is a slowing down of the firing motion (a slowing down ofthe rotation of the motor(s) which drive the sled, knife and/or firingbar), the process continues 5730 the closing motion originally initiated5712 but at a reduced speed and the interim process 5714-5726 iscontinued but the firing of the sled, knife and/or firing bar occurs ata reduced speed. When the change of the firing motion 5728 is a stoppingor pausing of the firing motion (a stopping or pausing of the rotationof the motor(s) which drive the sled, knife and/or firing bar), theprocess suspends or terminates 5732 the firing motion.

In accordance with one or more aspects, the operation of the surgicalinstrument 5700 may be controlled by monitoring parameters of the firingforce signal (e.g., the amplitude, the slope, etc.) and in cases where apredetermined threshold is reached or exceeded, deciding whether changethe firing motion based on the monitored parameters or to ignore thereaching or exceeding of the predetermined threshold. For example, inaccordance with one or more aspects, if the change of the firing force Fover time t (e.g., the slope of the firing force signal) reaches orexceeds a predetermined threshold before the firing force F reaches orexceeds a first firing force threshold, the control algorithm may ignorethe fact that the slope of the firing force signal reached or exceededthe predetermined threshold and allow the operation of the surgicalinstrument 5700 to proceed as if the slope of the firing force signalhad never reached or exceed the predetermined threshold.

FIG. 117 illustrates an example graph 5740 showing a curve 5742representative of a firing force F over time t for various aspects ofthe surgical instrument 5700. The firing force F is shown along thevertical axis and the time t is shown along the horizontal axis. Stateddifferently, the curve 5742 is a graphical representation of the firingforce signal at various times during a firing motion. The curve 5742 maybe generated mathematically by the controller based on the firing forcesignal(s) received by the controller. The firing force F shown in theexample graph 5740 may be representative of a condition where thethickness and composition of the tissue along the cut line is uniform.The firing force F represented on the vertical axis may be a forceexperienced by the drive system of the surgical instrument 1000 (e.g.,by the sled, the knife, and/or the firing bar), and/or any combinationthereof. The firing force F can be measured in any suitable manner,either directly or indirectly. For example, in accordance with one ormore aspects, the firing force F can be measured directly by a sensor(e.g., a strain gauge) positioned on the sled, on the knife, orindirectly by a current draw of the motor, and/or any combinationthereof.

For the example graph 5740 shown in FIG. 117, at time t=0, the knife isin a fully retracted position near the proximal end of the end effectorand over time advances to a fully advanced position near the distal endof the end effector. As described hereinabove, the overall distance theknife moves from the fully retracted position to the fully advancedposition during a firing motion can be divided into predefined zones,with each zone being representative of a different operating conditionof the surgical instrument 5700. Although not shown in FIG. 117 forpurposes of simplicity, the respective zones of the firing motion (e.g.,zones 1-5 as described hereinabove) could also be shown along thehorizontal axis of FIG. 117.

Shortly after the knife moves from its fully retracted position towardsits fully advanced position, the change of the firing force F over timet reaches or exceeds a predetermined slope threshold (this condition isshown as the slope A of the firing force signal in FIG. 117). As theslope A occurs in this example prior to the firing force F reaching orexceeding a first firing force threshold (shown as F1 in FIG. 117), thecontrol algorithm may ignore the fact that the slope A reached orexceeded the predetermined threshold and allow the operation of thesurgical instrument 5700 to proceed as if the slope A had never reachedor exceed the predetermined threshold. Similarly, the control algorithmcould also ignore the Slope A trigger, threshold or event based on theposition of the knife (e.g., if the knife was in zone 2 of the firingmotion when the predetermined slope threshold was reached or exceeded).

Due to the slope A trigger, threshold and/or event effectively beingignored, the knife continues to advance toward the fully advancedposition and the firing force F continues to rise over time t. As shownin FIG. 117, the slope of the firing force signal again reaches orexceeds the predetermined slope threshold (this instance is shown as theslope A1 of the firing force signal in FIG. 117). In accordance with oneor more aspects, the reaching or exceeding of the predetermined slopethreshold alone is sufficient for the control algorithm to change thefiring motion to slow down, stop or pause the further advancement of theknife. According to other aspects, the reaching or exceeding of thepredetermined amplitude threshold (e.g., the amplitude Fcrit shown inFIG. 117) alone is sufficient for the control algorithm to change thefiring motion to slow down, stop or pause the further advancement of theknife. According to yet other aspects, the combination of the reachingor exceeding of the predetermined slope threshold and the reaching orexceeding of the predetermined amplitude threshold causes the controlalgorithm to change the firing motion to slow down, stop or pause thefurther advancement of the knife. As shown in FIG. 117, when the slopeA1 of the firing force signal reaches or exceeds the predetermined slopethreshold and the amplitude of the firing force signal reaches orexceeds the predetermined amplitude threshold (e.g., Fcrit), the controlalgorithm changes the firing motion to slow down, stop or pause thefurther advancement of the knife and the firing force F begins todecrease.

The slowing down, stopping or pausing of the knife continues until thefiring force F reaches a value which is 10% less than the predeterminedamplitude threshold (e.g., Fcrit), at which point the furtheradvancement of the knife is commenced. Of course, in accordance with oneor more aspects, the further advancement of the knife can be commencedwhen the firing force reaches a value which is less than or more thanthe 10% example shown in FIG. 117. For the example graph 5742, once thefurther advancement of the knife is commenced, the knife advances to itsfully advanced position and the firing force decreases to zero asindicated at the far right side of FIG. 117.

According to other aspects, the decision to change the firing motion orto ignore the reaching or exceeding of the predetermined threshold maybe further based on the position of the sled, knife, firing bar orcombinations thereof. For example, in accordance with one or moreaspects, if the change of the firing force over time t reaches orexceeds a predetermined threshold while the knife is within a certainzone of the firing motion (e.g., zone 2 or zone 4), the controlalgorithm may ignore the fact that the slope of the firing force signalreached or exceeded the predetermined threshold and allow the operationof the surgical instrument 5700 to proceed as if the slope of the firingforce signal had never reached or exceed the predetermined threshold.

FIG. 118 illustrates an example graph 5750 showing a curve 5752representative of a firing force F over time t for various aspects ofthe surgical instrument 5700. The curve 5752 may be generatedmathematically by the controller based on the firing force signal(s)received by the controller. The firing force F shown in the examplegraph 5750 may be representative of a condition where the thickness andcomposition of the tissue along the cut line is uniform. The firingforce F represented on the vertical axis may be a force experienced bythe drive system of the surgical instrument 5700 (e.g., by the sled, theknife, and/or the firing bar), and/or any combination thereof. Althoughnot shown for purposes of simplicity, the respective zones of the firingcycle (e.g., zones 1-5 as described hereinabove) could also be shownalong the horizontal axis.

The firing force F can be measured in any suitable manner, eitherdirectly or indirectly. For example, in accordance with one or moreaspects, the firing force F can be measured directly by a sensor (e.g.,a strain gauge) positioned on the sled, on the knife, or indirectly by acurrent draw of the motor, and/or any combination thereof.

For the example graph 5750 in FIG. 118, at time t=0 the knife is in thefully-retracted position and the firing force F is zero. As the knifeand sled advance and the velocity of the knife increases, the firingforce F increases and reaches a first peak value 5754 when a first rowof staples is driven from the staple cartridge. After the first row ofstaples is driven as described hereinabove, the firing force F decreasesuntil a second row of staples is driven, which causes the firing force Fto reach a second peak value 5756.

At a later point in the firing motion, the slope of the firing forcesignal reaches or exceeds a predetermined threshold (this condition isshown as the slope A1 of the firing force signal in FIG. 118) and theamplitude of the firing force F reaches or exceeds a predeterminedamplitude threshold (e.g., the amplitude Fcrit shown in FIG. 118). Inresponse, the control algorithm acts to slow down, stop or pause thefurther advancement of the knife and the firing force F begins todecrease.

For the example graph 5752, the slowing down, stopping or pausing of theknife continues until the firing force F reaches a value which is 10%less than the predetermined amplitude threshold (e.g., Fcrit), at whichpoint the further advancement of the knife is commenced. Of course, inaccordance with one or more aspects, the further advancement of theknife can be commenced when the firing force reaches a value which isless than or more than the 10% example shown in FIG. 118. Theabove-described automatic stopping or pausing and automatic restartingmay be repeated any number of times.

For the example graph 5752, once the further advancement of the knife iscommenced, as the knife advances towards its fully advanced position theslope of the firing force signal once again reaches or exceeds thepredetermined slope threshold (this condition is shown as the slope A2of the firing force signal in FIG. 118). However, because thepredetermined slope threshold was reached or exceeded while the knifewas in zone 4 of the firing motion, the control algorithm ignores this“slope” trigger and continues advancing the knife to its fully advancedposition, resulting in the firing force decreasing to zero as indicatedat the far right side of FIG. 118.

In addition to ignoring triggers, thresholds and/or events based onwhere the triggers, thresholds and/or events occur within the firingmotion, the control algorithms may also vary or modify the triggers,thresholds and/or events based on where the triggers, thresholds and/orevents occur within the firing motion. For example, in accordance withone or more aspects, the control algorithms may set the value for apredetermined slope threshold at a first value for zone 1 of the firingmotion, at a second value for zone 2 of the firing motion, at a thirdvalue for zone 3 of the firing motion, etc.

FIG. 119 illustrates an example graph 5770 showing a curverepresentative of a closing force FC over time t for various aspects ofthe surgical instrument and a curve representative of a firing force FFover time t for the surgical instrument 5700 of FIG. 115. FIG. 119illustrates an example graph 5770 showing a curve 5772 representative ofa closing force FC over time t for various aspects of the surgicalinstrument 5700 and a curve 5774 representative of a firing force FFover time t for various aspects of the surgical instrument 5700. Theclosing force FC is shown along the “left” vertical axis, the firingforce FF is shown along the “right” vertical axis and the time t isshown along the horizontal axis. When viewed together the curves 5772,5774 reflect the timing of the closing motion and the firing motionrelative to one another, where the closing motion is initiated prior tothe initiation of the firing motion. Although the example graph 5770shows a threshold force Fcrit as being the same amplitude for both theclosing force FC and the firing force FF, it will be appreciated thatthe amplitude of the threshold force Fcrit for the closing force FC maybe different from the amplitude of the threshold force Fcrit for thefiring force FF. Stated differently, the scale of the “left” verticalaxis can be different from the scale of the “right” vertical axis.

The curve 5772 is a graphical representation of the closing force signalat various times during a closing motion. Thus, as set forthhereinabove, the curve 5772 may be generated mathematically by thecontroller based on the closing force signal(s) received by thecontroller. The closing force FC represented on the “left” vertical axismay be a force experienced by tissue clamped between the jaws of thesurgical instrument 5700, a force experienced by the jaws of thesurgical instrument 5700 (e.g., by the anvil and/or the elongatedchannel), a force experienced by the closure tube of the surgicalinstrument 5700, and/or any combinations thereof. The closing force FCcan be measured in any suitable manner, either directly or indirectly.For example, according to various aspects, the closing force FC can bemeasured directly by a sensor (e.g., a strain gauge) positioned on theanvil, on the elongated channel, on the closure tube, or indirectly byan impedance of the tissue, a current draw of the motor, and/or anycombinations thereof.

The curve 5774 is a graphical representation of the firing force signalat various times during a firing motion and may be similar or identicalto the curve 5752 of FIG. 109. Thus, as set forth hereinabove, the curve5774 may be generated mathematically by the controller based on thefiring force signal(s) received by the controller. The firing force FFrepresented on the “right” vertical axis may be a force experienced bythe drive system of the surgical instrument 5700 (e.g., by the sled, theknife, and/or the firing bar), and/or any combination thereof. Thefiring force FF can be measured in any suitable manner, either directlyor indirectly. For example, according to various aspects, the firingforce FF can be measured directly by a sensor (e.g., a strain gauge)positioned on the sled, on the knife, or indirectly by a current draw ofthe motor, and/or any combination thereof. Although not shown forpurposes of simplicity, the respective zones of the firing cycle (e.g.,zones 1-5 as described hereinabove) could also be shown along thehorizontal axis.

For the example graph 5770 in FIG. 110, at some time after the closingmotion has commenced, the knife is still in the fully-retracted positionand the firing force FF is approximately zero. As the knife and sledadvance and the velocity of the knife increases, the firing force FFincreases and reaches a first peak value 5776 when a first row ofstaples is driven from the staple cartridge. After the first row ofstaples is driven as described hereinabove, the firing force FFdecreases until a second row of staples is driven, which causes thefiring force FF to reach a second peak value 5778.

At a later point in the firing motion, the slope of the firing forcesignal reaches or exceeds a predetermined threshold (this condition isshown as the slope A of the firing force signal in FIG. 117) and theamplitude of the firing force FF reaches or exceeds a predeterminedamplitude threshold (e.g., the amplitude Fcrit shown in FIG. 117). Inresponse, the control algorithm acts to slow down, stop or pause thefurther advancement of the knife and the firing force FF begins todecrease.

For the example graph 5770, the slowing down, stopping or pausing of theknife continues until the firing force FF reaches a value which is 10%less than the predetermined amplitude threshold (e.g., Fcrit), at whichpoint the further advancement of the knife is commenced. Of course,according to various aspects, the further advancement of the knife canbe commenced when the firing force FF reaches a value which is less thanor more than the 10% example shown in FIG. 117. The above-describedautomatic stopping or pausing and automatic restarting may be repeatedany number of times.

For the example graph 5770, once the further advancement of the knife iscommenced, as the knife advances towards its fully advanced position theslope of the firing force signal once again reaches or exceeds thepredetermined slope threshold (this condition is shown as the slope B ofthe firing force signal in FIG. 117). However, because the predeterminedslope threshold was reached or exceeded while the knife was in zone 4(not shown) of the firing motion, the control algorithm ignores this“slope” trigger and continues advancing the knife to its fully advancedposition, resulting in the firing force decreasing to zero as indicatedat the far right side of FIG. 117.

FIG. 120 illustrates an example graph 5760 showing a first curve 5762representative of a firing force F over time t for various aspects ofthe surgical instrument 5700, a knife position X over time t for variousaspects of the surgical instrument 5700 and a second curve 5764representative of knife velocity V over time t for various aspects ofthe surgical instrument 5700. The firing force F is shown along the topvertical axis, the knife velocity V is shown along the bottom verticalaxis, the knife position X is shown along the top horizontal axis andthe time t are shown along both the top and bottom the horizontal axes.As shown along the top horizontal axis, the knife position X travelsover five Zones 1-5 along the knife channel in the cartridge 304 locatedin the lower jaw 302 of the end effector 300 of the surgical instrument5700. The knife velocity V and the firing force F shown in FIG. 120 maybe based on the assumption that the thickness and composition of thetissue along the cut line is uniform.

Accordingly, the curve 5762 is a representation of the firing forcesignal at various times during a firing motion and the curve 5764 is arepresentation of the knife velocity signal at various times during afiring motion. The curves 5762, 5764 may be generated mathematically bythe controller based on the firing force signal(s) and the knifevelocity signal(s) received by the controller. The firing force Frepresented on the top vertical axis may be a force experienced by thedrive system of the surgical instrument 5500 (e.g., by the sled, theknife and/or the firing bar), and/or any combination thereof. The firingforce F can be measured in any suitable manner, either directly orindirectly. For example, in accordance with one or more aspects, thefiring force F can be measured directly by a sensor (e.g., a straingauge) positioned on the sled, on the knife, or indirectly by a currentdraw of the motor, and/or any combination thereof.

The knife velocity V represented on the bottom vertical axis may be avelocity of the knife, a velocity of the sled, a velocity of anothercomponent of the drive system (e.g., the firing bar), and/or anycombination thereof. The knife velocity V can be measured in anysuitable manner, either directly or indirectly. For example, inaccordance with one or more aspects, the knife velocity V can bemeasured directly by a combination of a magnet positioned on the firingbar and a Hall-effect sensor or indirectly by a current draw of themotor, an encoder coupled to the shaft of the motor, and/or anycombination thereof.

For the example graph 5764, the knife velocity V is shown as increasingfrom zero to a substantially maximum velocity while the knife advancesfrom its fully retracted position through zone 1 and into zone 2 of thefiring motion. Even if the change of the firing force F over time (e.g.,the slope ΔF/Δt shown occurring in zone 1 and/or zone 2) reaches orexceeds a predetermined threshold, the control algorithm may ignore thistrigger, threshold and/or event and allow the knife to continueadvancing as shown by the knife velocity V in FIG. 120. Once thesubstantially maximum velocity is reached in zone 2, the knife continuesto advance in zone 2 and zone 3 until another trigger, threshold and/orevent prompts the control algorithm to automatically stop theadvancement of the knife. For the example graph 5762, this occurs inzone 3 when the firing force F exceeds the predetermined thresholdFcrit. According to other aspects, the trigger, threshold and/or eventcould be a change of firing force F over time t reaching or exceeding acertain value, a combination of the change of firing force F over time treaching or exceeding a certain value and the firing force F reaching orexceeding a certain value, a change of a peak-to-peak firing force overtime t reaching or exceeding a certain value, a combination of a changeof a peak-to-peak firing force over time t reaching or exceeding acertain value and the firing force F reaching or exceeding a certainvalue, etc.

Once the firing force F reaches or exceeds the predetermined thresholdFcrit and the knife is in a position associated with zone 3 of thefiring motion, the control algorithm automatically stops or pauses thefurther advancement of the knife and the knife velocity V falls from asubstantially constant velocity to zero at time t1. In other words,instead of ignoring the trigger, the control algorithm acts on thetrigger and changes the firing motion. After a predefined period of time(e.g., the time period t2-t1) as shown in FIG. 120 or a predefined dropin the amplitude of the firing force F, the control algorithmautomatically restarts the advancement of the knife and the knifevelocity V increases from zero at time t2 to a substantially maximumvelocity, then continues in zone 3 and zone 4 at a substantiallyconstant velocity. At some point in zone 4, the knife velocity dropsfrom a substantially constant velocity to zero and the firing force alsodrops to zero.

Although FIG. 120 depicts the control algorithm as not acting on afiring force trigger, threshold and/or event which occurs in zone 2 ofthe firing motion and acting on a firing force trigger, threshold and/orevent which occurs in zone 3 of the firing motion, it will beappreciated that the control algorithm can be configured to act or notact on firing force triggers, thresholds and/or events which occur inother zones of the firing motion. For example, as described hereinabovewith respect to FIG. 118, the control algorithm can be configured to notact (ignore) a firing force trigger, threshold and/or event which occursin zone 4 of the firing motion.

Furthermore, although the functionality of the control algorithmsdescribed in connection with FIGS. 115-120 were described in the contextof ignoring or varying triggers, thresholds and/or events during thefiring motion, it will be appreciated that the control algorithms of thesurgical instrument 5700 may also be configured to ignore or varytriggers, thresholds and/or events during the closing cycle (i.e., theclosing of the jaws).

FIG. 121 illustrates a perspective view of a surgical instrument 5800according to various aspects described herein. The surgical instrument5800 is similar to the surgical instrument 5500 and includes anelongated channel configured to support a staple cartridge, an anvilpivotably connected to the elongated channel, a closure membermechanically coupled to the anvil, a knife mechanically coupled to thestaple cartridge, an electric motor mechanically coupled to the closuremember and/or the knife, a motor controller electrically coupled to themotor, and a control circuit electrically coupled to the motorcontroller. The surgical instrument 5800 is also similar to the surgicalinstrument 5500 in that the surgical instrument 5800 also includessensors which are collectively configured to sense or measure a closingforce, a firing force, a current drawn by the electric motor, animpedance of tissue positioned between the elongated channel and theanvil, a position of the anvil relative to the elongated channel, aposition of the knife, or any combination thereof. The surgicalinstrument 5500 is also similar to the surgical instrument 5800 in thatthe surgical instrument 5800 also includes algorithms such as closingalgorithms, firing algorithms, motor control algorithms, or anycombination thereof, which operate to dynamically adjust the operationof the surgical instrument 5800. However, the surgical instrument 5800is different from the surgical instrument 5500 in that the surgicalinstrument 5800 further includes one or more additional algorithms (inaddition to those described hereinabove) which provide additionalcontrol functionality for the surgical instrument 5800, as describedherein below.

In certain aspects, for different circumstances, the control algorithmsare configured to automatically invoke different adjustments to theclosing motion and/or the firing motion. For example, in certainaspects, a control algorithm is configured to adjust the firing motionbased on how fast the load is increasing or decreasing as it approachesa predefined staged threshold. For such aspects, a first adjustment tothe firing motion may be invoked when the load is increasing at a firstrate as it approaches a predefined threshold, and a second adjustment tothe firing motion may be invoked when the load is increasing at a secondrate as it approaches a predefined threshold. In other aspects, thecontrol algorithms are configured to adjust the closure algorithm and/orthe firing algorithm based on how fast aspects of the closing force, theclosure tube velocity, the firing force, the knife velocity, the motorcurrent and combinations thereof are increasing or decreasing as theyapproaches respective predefined staged thresholds.

FIG. 122 illustrates a method 5810 of controlling a firing motion of thesurgical instrument 5800 according to various aspects. The processstarts when a firing motion is initiated 5812. The firing motion may beinitiated, for example, by pulling a firing trigger toward a handle. Asensor resident with the surgical instrument 5800 senses/measures 5814 afiring force. The firing force may be, for example, a force experiencedby the drive system of the surgical instrument (e.g., by the sled, theknife and/or the firing bar), and/or any combination thereof. The firingforce F can be measured in any suitable manner, either directly orindirectly. For example, according to various aspects, the firing forceF can be measured directly by a sensor (e.g. a strain gauge) positionedon the sled, on the knife, or indirectly by a current draw of the motor.

In response to the firing force, the sensor outputs 5816 a firing forcesignal, which is indicative of the firing force sensed/measured 5814 bythe sensor. Depending on the configuration of the sensor, the firingforce signal can be an analog signal or a digital signal. Upondetermining 5818 whether the firing force signal is either an analogsignal or a digital signal, the process proceeds along the correspondingbranch. When the determination 5818 is that the firing force signal isan analog signal, the process proceeds along the analog branch, wherethe analog signal is received by an A/D converter, converted 5820 to adigital signal representative of the analog signal by the A/D converterand the digital signal is output by the A/D converter. When thedetermination 5818 is that the firing force signal is a digital signal,the process proceeds along the digital branch because there is no needfor an A/D conversion 5820 when the firing force signal is a digitalsignal.

The firing force signal which is a digital signal representative of thefiring force sensed/measured 5814 by the sensor is received by acontroller. The controller utilizes the digital signal and determines5822 a projected peak firing force. According to various aspects, theprojected peak firing force is determined by constructing a straightline which passes through the two most recent peak values of the firingforce signal, projecting when the next peak firing force will occur anddetermining the value of the firing force on the straight line at thattime. The straight line is representative of a change of peak firingforce values over time and may thus be considered a slope of the peakfiring force values. The controller may project when the next peakfiring force will occur in any suitable manner. For example, accordingto various aspects, the controller may utilize the time lapse betweenthe last two peak firing forces, the average of the time lapses betweeneach of the peak firing forces which have occurred in a given firingmotion, the pattern or trend of the time lapses between each of the peakfiring forces which have occurred in a given firing motion andcombinations thereof.

After the controller determines 5822 that the projected peak firingforce, the controller then determines 5824 whether or not the firingmotion should be changed. The determination 5824 may be based, forexample, on how fast or slow the projected peak firing force isapproaching a predetermined threshold, on the amplitude of the firingforce and how fast or slow the projected peak firing force isapproaching a predetermined threshold, and combinations thereof. Inother words, the determination 5824 may be based on the amplitude of thefiring force and the value of the slope of the peak firing force valuesas the slope is approaching a predetermined threshold. The predeterminedthreshold may be any suitable threshold such as, for example, apredetermined firing force threshold. When the controller determines5824 that the firing motion should not be changed, the firing motionoriginally initiated 5812 is continued 5826 along with interim processes5814-5824. When the controller determines 5824 that the motion should bechanged, the firing motion may be changed in a multitude of differentways, with the particular way determined based on how fast or slow theprojected peak firing force is approaching a predetermined threshold.

According to various aspects, when the projected peak firing force isapproaching a predetermined threshold at a first rate, the controllermay stop or pause 5828 the firing motion by communicating a stop signalor a pause signal to the motor controller to stop or pause the rotationof the motor(s) which drive the sled, knife, firing bar or anycombination thereof of the surgical instrument 5800. After the firingmotion is stopped or paused, the firing motion may be subsequentlyterminated 5830 or the controller may restart 5832 the firing motion bycommunicating a restart signal to the motor controller to restart therotation of the motor(s) which drive the sled, knife, firing bar or anycombination thereof of the surgical instrument 5800. The firing motionmay be restarted 5832 based on, for example, a period of time, apredetermined drop in the firing force and combinations thereof. Afterthe firing motion is restarted 5832, interim processes 5814-5824 of thefiring motion originally initiated 5812 are continued.

According to various aspects, when the projected peak firing force isapproaching a predetermined threshold at a second rate, the controllermay change the firing motion to decrease the knife velocity 5834 bycommunicating a slow down signal to the motor controller to slow downthe rotation of the motor(s) which drive the sled, knife, firing bar orany combination thereof of the surgical instrument 5800. Similarly,according to various aspects, when the projected peak firing force isapproaching a predetermined threshold at a third rate, the controllermay change the firing motion to increase the knife velocity 5836 bycommunicating a speed up signal to the motor controller to speed up therotation of the motor(s) which drive the sled, knife, firing bar or anycombination thereof of the surgical instrument 5800.

According to various aspects, when the projected peak firing force isapproaching a predetermined threshold at a fourth rate, the controllermay change the firing motion to oscillate the knife 5838 bycommunicating an oscillation signal to the motor controller to alternatethe rotation of the motor(s) which drive the sled, knife, firing bar orany combination thereof of the surgical instrument 5800 in a clockwisedirection and a counterclockwise direction, thereby producing a back andforth motion of the sled, knife, firing bar or any combination thereof.

FIG. 123 illustrates an example graph 5850 showing a first curve 5852representative of a firing force F over time t for various aspects ofthe surgical instrument 5800, a knife position X over time t for variousaspects of the surgical instrument 5800 and a second curve 5854representative of knife velocity V over time t for various aspects ofthe surgical instrument 5800. The firing force F is shown along the topvertical axis, the knife velocity V is shown along the bottom verticalaxis, the knife position X is shown along both the top and bottomhorizontal axes and the time t is shown along both the top and bottomthe horizontal axes. As shown along the top an bottom horizontal axes,the knife position X travels over five zones (zones 1-5) along the knifechannel in the cartridge 304 located in the lower jaw 302 of the endeffector 300 of the surgical instrument 5800. The knife velocity V andthe firing force F shown in FIG. 123 may be based on the assumption thatthe thickness and composition of the tissue 5856 along the cut line isnon-uniform as shown on the far right side of FIG. 123.

Accordingly, the curve 5852 is a representation of the firing forcesignal at various times during a firing motion and the curve 5854 is arepresentation of the knife velocity signal at various times during afiring motion. The curves 5852, 5854 may be generated mathematically bythe controller based on the firing force signal(s) and the knifevelocity signal(s) received by the controller. The firing force Frepresented on the top vertical axis may be a force experienced by thedrive system of the surgical instrument 5800 (e.g., by the sled, theknife and/or the firing bar), and/or any combination thereof. The firingforce F can be measured in any suitable manner, either directly orindirectly. For example, according to various aspects, the firing forceF can be measured directly by a sensor (e.g., a strain gauge) positionedon the sled, on the knife, or indirectly by a current draw of the motor,and/or any combination thereof.

The knife velocity V represented on the bottom vertical axis may be avelocity of the knife, a velocity of the sled, a velocity of anothercomponent of the drive system (e.g., the firing bar), and/or anycombination thereof. The knife velocity V can be measured in anysuitable manner, either directly or indirectly. For example, accordingto various aspects, the knife velocity V can be measured directly by acombination of a magnet positioned on the firing bar and a Hall-effectsensor or indirectly by a current draw of the motor, an encoder coupledto the shaft of the motor, and/or any combination thereof.

For the example graph 5840, the curve 5854 shows the knife velocity Vincreasing from zero at time t=0 to a substantially maximum velocity V1while the knife advances from its fully retracted position through zone1 and into zone 2 of the firing motion. Once the substantially maximumvelocity V1 is reached in zone 2, the knife continues to advance in zone2 and zone 3 until a trigger, threshold and/or event prompts the controlalgorithm to automatically change the firing motion, in this casedecreasing the knife velocity V. Such a trigger, threshold or event isshown in the curve 5852, where the projected peak firing force on theslope (ΔF1/Δt1) reaches or exceeds a predetermined threshold (e.g., thefiring force value Fcrit) at the time t1. As shown in FIG. 123, the timet1 may correspond to the knife cutting through a portion of tissue 5856which is less than a full thickness of the tissue 5856.

Once the projected peak firing force on the slope (ΔF1/Δt1) reaches orexceeds the predetermined threshold Fcrit and the knife is in a positionassociated with zone 3 of the firing motion at time t1, the controlalgorithm changes the firing motion to decrease the knife velocity fromthe substantially maximum velocity V1 to the reduced velocity V2.Although the velocity V2 is shown as being approximately ⅔ of thevelocity V1, it will be appreciated that the decrease in the knifevelocity V can be more or less than ⅓ of the maximum velocity V1.According to various aspects, the amount of the decrease is based on thevalue of the slope (ΔF1/Δt1), essentially how quickly the peak firingforces are approaching the predetermined threshold. The knife thenadvances at the reduced velocity V2 in zone 3 until another trigger,threshold and/or event prompts the control algorithm to automaticallychange the firing motion, in this case further decreasing the knifevelocity V. Such a trigger, threshold or event is shown in the curve5852, where the projected peak firing force on the slope (ΔF2/Δt2)reaches or exceeds a predetermined threshold (e.g., the firing forcevalue Fcrit) at the time t2. As shown in FIG. 123, the time t2 maycorrespond to the knife cutting through a portion of tissue 5856 whichis the full thickness of the tissue 5856.

Once the projected peak firing force on the slope (ΔF2/Δt2) reaches orexceeds the predetermined threshold Fcrit and the knife is in a positionassociated with zone 3 of the firing motion at time t2, the controlalgorithm again changes the firing motion to further decrease the knifevelocity from the reduced V2 to the further reduced velocity V3.Although the velocity V3 is shown as being approximately ⅓ of thevelocity V1 and ½ of the velocity V2, it will be appreciated that thefurther decrease in the knife velocity V can be more or less than ⅓ ofthe maximum velocity V1 or more or less than ½ of the previous velocityV2. According to various aspects, the amount of the decrease is based onthe value of the slope (ΔF2/Δt2), essentially how quickly the peakfiring forces are approaching the predetermined threshold.

After the time t2, the knife continues advancing through zones 3 and 4of the firing motion at the velocity V2, then begins dropping in zone 4and reaches zero in zone 5of the firing motion. As shown in the curve5852, the firing force F also drops to zero in zone 5. Due to thedifferences in the knife velocity V brought about by the controller, itwill be appreciated that the time period Δt1, the time betweensuccessive valley firing force values when the knife is in zone 2 of thefiring motion and advancing at the velocity V1, is less than the timeperiod Δt2, the time between successive valley firing force values whenthe knife is in zone 3 of the firing motion and advancing at thevelocity V2, which is less than the time period Δt3, the time betweensuccessive valley firing force values when the knife is in zone 3 of thefiring motion and advancing at the velocity V3.

Although FIG. 123 depicts the control algorithm as acting to reduce theknife velocity V based on triggers, thresholds and/or events which occurin zones 2 and/or 3 of the firing motion, it will be appreciated thatthe control algorithm can be configured to act to increase the knifevelocity, oscillate the knife and combinations thereof in zones 2 and 3of the firing motion and/or in other zones of the firing motion. Forexample, when the peak firing forces are rapidly approaching apredetermined threshold (i.e., the slope is steep), the firing algorithmmay interpret this as an obstruction to the knife and change the firingmotion to stop the advancement of the knife then create an oscillatingmotion. The stop, backup, re-advance, stop, backup, re-advance patternassists the knife in moving through the obstruction.

Furthermore, although the functionality of the control algorithmsdescribed in connection with FIG. 123 were described in the context ofadjusting the knife velocity V, it will be appreciated that the controlalgorithms of the surgical instrument 5800 may also be configured toadjust the closure tube velocity during the closing motion (i.e., theclosing of the jaws). Similarly, the control algorithms may operate tochange the closing motion such that the anvil vibrates/oscillates towarda fully closed position to improve compression of the tissue 5856.

FIG. 124 illustrates the rate of closure of the jaws (jaws closurespeed) for the surgical instrument of FIG. 121 in accordance with one ormore aspects of the present disclosure. In other words, the rate ofclosure of the anvil 306 closing onto the staple cartridge 304 withtissue located therebetween. The top graph 5860 represents the jawsclosing at a constant speed where the jaw closing force (F) isrepresented along the vertical axis as the knife advances over alongitudinal distance (X) in the cartridge 304, as represented along thehorizontal axis, until the stop trigger is actuated by the controlprogram at X1. The stop trigger stops the jaws from closing for a periodof time prior to initiating the firing stroke. As previously describedherein, this enables the jaws to squeeze excess moisture from the tissueprior to initiating the firing stroke after a brief delay period of 5 to20 seconds and preferably about 15 seconds. At X1, the jaws closingforce reaches a peak amplitude and the gap between the jaws is set to apredetermined distance. Still with reference to the top graph 5860, thefirst curve 5862 represents the force over distance as the jaws close ata first constant speed until the stop trigger stops the jaws fromclosing at X1. At this point, the force F reaches a peak force of F1 andthe gap between the jaws is set to a first distance. The second curve5864 represents the force over distance as the jaws close at a secondspeed, which is less than the first speed, until the stop trigger stopsthe jaws from closing at X1. The first jaw closing speed is adjusted tothe second closing speed by the control circuit when the control circuitpredicts that the closing force will be too high. At X1, the force Freaches a peak force of F2, which is less than F1, and the gap betweenthe jaws is set to a second distance which is less than the firstdistance.

With reference still to FIG. 124, the bottom graph 5866 represents thejaws closing force (F) along the vertical axis and time (t) along thehorizontal axis. The first curve 5867 represents the jaws closing forceover time as the jaws close at a constant speed. As shown by the firstcurve 5867, when the jaws closing speed is constant, the jaws canexperience a force that reaches a maximum F1 that is too high andreaches this peak force F1 before the stop trigger is activated.Accordingly, when the control circuit predicts that the jaws closingforce will be high, the control circuit slows down the jaws closurespeed after a period of t1. At the lower jaw closing speed the secondcurve 5869 can lead to a lower force (and a lower gap) and ultimately alower peak force F2 (and gap) after a period t2 prior to initiating afiring stroke. As shown, the stop trigger actually changes speed thekeep the jaws closing force F below the slope threshold 5868.

In various aspects, the control algorithms operate to effectively takecontrol of the surgical instrument during the closing and/or firingmotions. In certain aspects, a control algorithm automatically operatesthe surgical instrument in a cutting mode which optimizes staple form.For example, an exemplary control algorithm advances the knife in threeincremental stages to optimize staple form. In the first stage, theknife is advanced distally a small increment (e.g., 3mm) and is thenstopped. Pressure applied to the tissue near the knife operates to forcefluid out of the tissue. The knife remains stopped until a predeterminedtime passes, a sensor (pressure, distance, etc.) in the distal shaftindicates an asymptote, and combinations thereof. In the second stage,the knife is retracted proximally a smaller distance (e.g., 1 mm) fromthe first stage stopping point and is then stopped. The distance betweenthe first stage stopping point and the second stage stopping pointallows for the knife acceleration which occurs in the third stage. Inthe third stage, the knife is driven distally at a rapid speed untilsufficient knife advancement is made to drive/form one staple (or onerow of staples). The high speed move forms the staple quickly, reducingthe chances of staple buckling and improving form quality. High speedforming is a technique used in nail guns, particularly in finishingnails that are extremely prone to buckling. The three stages arerepeated for each row of staples for the length of the cut, effectivelyratcheting through the tissue.

According to certain aspects, the surgical instrument includes a buttonwhich can be utilized by an operator to selectively enable or disablethe above-described cutting mode. The button may be positioned on theshaft. Although the cutting mode was described as a cutting mode whichoptimizes staple form, it will be appreciated that according to otheraspects the control algorithm may operate the surgical instrument in acutting mode which is different than that described hereinabove.

In certain instances, in lieu of the closing motion or the firing motionbeing changed or modified based on upon the occurrence of a singletrigger, threshold and/or event, the closing motion or the firing motionmay be changed or modified based on a combination of triggers,thresholds, events and/or combinations thereof.

FIG. 125 illustrates a perspective view of a surgical instrument 5900according to various aspects described herein. The surgical instrument5900 is similar to the surgical instrument 5500 and includes anelongated channel configured to support a staple cartridge, an anvilpivotably connected to the elongated channel, a closure membermechanically coupled to the anvil, a knife mechanically coupled to thestaple cartridge, an electric motor mechanically coupled to the closuremember and/or the knife, a motor controller electrically coupled to themotor, and a control circuit electrically coupled to the motorcontroller. The surgical instrument 5900 is also similar to the surgicalinstrument 5500 in that the surgical instrument 5900 also includessensors which are collectively configured to sense or measure a closingforce, a firing force, a current drawn by the electric motor, animpedance of tissue positioned between the elongated channel and theanvil, a position of the anvil relative to the elongated channel, aposition of the knife, or any combination thereof. The surgicalinstrument 5900 is also similar to the surgical instrument 5500 in thatthe surgical instrument 5900 also includes algorithms such as closingalgorithms, firing algorithms, motor control algorithms, or anycombination thereof, which operate to dynamically adjust the operationof the surgical instrument 5900. However, the surgical instrument 5900is different from the surgical instrument 5500 in that the surgicalinstrument 5900 further includes one or more additional algorithms (inaddition to those described hereinabove) which provide additionalcontrol functionality for the surgical instrument 5900, as describedhereinbelow.

In certain aspects, the control algorithms are configured toautomatically invoke different adjustments to the closing motion and/orthe firing motion based on a combination of different triggers. Forexample, in certain aspects, a control algorithm is configured to adjustthe firing motion to limit the maximum velocity of the knife, reduce theknife velocity by 50%, apply a pre-programmed knife velocity profile,only halt the firing motion and retract the knife, only complete thecurrent firing motion, etc. based on a combination of differenttriggers. Such triggers may include, for example, a slope value of thefiring force signal at the time a threshold is reached or exceeded, aslope value of the peak firing force values, a number of thresholdsreached or exceeded within a given time interval, and thresholds reachedor exceeded for multiple parameters (e.g., current, force, velocity,acceleration).

FIGS. 126A and 126B illustrate a method 5910 of controlling a firingmotion of the surgical instrument 5900 according to various aspects. Theprocess starts when a firing motion is initiated 5912. The firing motionmay be initiated, for example, by pulling a firing trigger toward ahandle. A start/stop counter of the surgical instrument 5900 isinitially set to zero prior to or at the time the firing motion isoriginally initiated 5912. A sensor resident with the surgicalinstrument 5900 senses/measures 5914 a firing force. The firing forcemay be, for example, a force experienced by the drive system of thesurgical instrument (e.g., by the sled, the knife and/or the firingbar), and/or any combination thereof. The firing force can be measuredin any suitable manner, either directly or indirectly. For example,according to various aspects, the firing force can be measured directlyby a sensor (e.g. a strain gauge) positioned on the sled, on the knife,or indirectly by a current draw of the motor.

In response to the firing force, the sensor outputs 5916 a firing forcesignal, which is indicative of the firing force sensed/measured 5914 bythe sensor. Depending on the configuration of the sensor, the firingforce signal can be an analog signal or a digital signal. Upondetermining 5918 whether the firing force signal is either an analogsignal or a digital signal, the process proceeds along the correspondingbranch. When the determination 5918 is that the firing force signal isan analog signal, the process proceeds along the analog branch, wherethe analog signal is received by an A/D converter, converted 5920 to adigital signal representative of the analog signal by the A/D converterand the digital signal is output by the A/D converter. When thedetermination 5918 is that the firing force signal is a digital signal,the process proceeds along the digital branch because there is no needfor an A/D conversion 5920 when the firing force signal is a digitalsignal.

The firing force signal which is a digital signal representative of thefiring force sensed/measured 5914 by the sensor is received by acontroller. The controller utilizes the digital signal and determines5922 whether the firing force sensed/measured 5914 by the sensor reachesor exceeds a predetermined threshold. Of course according to variousaspects, the predetermined threshold can be other than a firing forcethreshold. For example, according to various aspects, the predeterminedthreshold can be a given amplitude of the firing force signal, a slopevalue of the peak firing force values, how fast or slow a slope of thepeak firing forces is approaching a predetermined threshold, a currentdrawn by the motor, and combinations thereof.

When the controller determines 5922 that a predetermined threshold hasnot been reached or exceeded, the firing motion originally initiated5912 is continued 5924 along with interim processes 5914-5922. When thecontroller determines 5922 that a predetermined threshold has beenreached or exceeded, the controller then determines 5926 if the knifeadvancement should be stopped/paused. In certain instances, depending onthe position of the knife (which zone of the firing motion the knife isin), the advancement of the knife may be continued even if apredetermined threshold has been reached or exceeded. When thecontroller determines 5926 the advancement of the knife should not bepaused/stopped, the firing motion originally initiated 5912 is continued5924 along with interim processes 5914-5922.

When the controller determines 5926 the advancement of the knife shouldbe paused/stopped (i.e., the trigger is not ignored), the controllercommunicates a stop signal or a pause signal to the motor controller tostop or pause the rotation of the motor(s) which drive the knife of thesurgical instrument 5900 and the controller increments 5928 thestart/stop counter from zero to one. The controller reads the start/stopcounter and determines 5930 whether the count of the start/stop counterhas reached or exceed a predetermined threshold. The predeterminedthreshold may be any suitable whole number. For example, according tovarious aspects, the predetermined threshold for the value of thestart/stop counter is three.

When the controller determines 5930 the count of the start/stop counterhas not reached or exceed the predetermined threshold, the advancementof the knife may be restarted after a predetermined period of time, oncethe firing force has dropped a predetermined amount, and combinationsthereof, and the interim processes 5914-5930 are continued. When thecontroller determines 5930 the count of the start/stop counter hasreached or exceed the predetermined threshold, the controller ends 5932the firing motion by communicating signals to the motor controller toreverse the rotation of the motor(s) which drive the knife of thesurgical instrument 5900, thereby retracting the knife to its fullyproximal position then (2) stop the “reversing” rotation of themotor(s), thereby ending 5932 the firing motion originally initiated5912. When the firing motion is ended 5932, the controller may reset5934 the start/stop counter to zero and the jaws of the surgicalinstrument 5900 may then be opened and removed from the tissue site.

FIG. 127 illustrates an example graph 5950 showing a first curve 5952representative of a firing force F over time t for various aspects ofthe surgical instrument 5900, a knife position X over time t for variousaspects of the surgical instrument 5900 and a second curve 5954representative of knife velocity V over time t for various aspects ofthe surgical instrument 5900. The firing force F is shown along the topvertical axis, the knife velocity V is shown along the bottom verticalaxis, the knife position X is shown along both the top and bottomhorizontal axes and the time t is shown along both the top and bottomhorizontal axes. As shown along the top and bottom horizontal axes, theknife position X travels over five zones (zones 1-5) along the knifechannel in the cartridge 304 located in the lower jaw 302 of the endeffector 300 of the surgical instrument 5900. The knife velocity V andthe firing force F shown in FIG. 127 may be based on the assumption thatthe thickness and composition of the tissue along the cut line isnon-uniform.

Accordingly, the curve 5952 is a representation of the firing forcesignal at various times during a firing motion and the curve 5954 is arepresentation of the knife velocity signal at various times during afiring motion. The curves 5952, 5954 may be generated mathematically bythe controller based on the firing force signal(s) and the knifevelocity signal(s) received by the controller. The firing force Frepresented on the top vertical axis may be a force experienced by thedrive system of the surgical instrument 5900 (e.g., by the sled, theknife and/or the firing bar), and/or any combination thereof. The firingforce F can be measured in any suitable manner, either directly orindirectly. For example, according to various aspects, the firing forceF can be measured directly by a sensor (e.g., a strain gauge) positionedon the sled, on the knife, or indirectly by a current draw of the motor,and/or any combination thereof.

The knife velocity V represented on the bottom vertical axis may be avelocity of the knife, a velocity of the sled, a velocity of anothercomponent of the drive system (e.g., the firing bar), and/or anycombination thereof. The knife velocity V can be measured in anysuitable manner, either directly or indirectly. For example, accordingto various aspects, the knife velocity V can be measured directly by acombination of a magnet positioned on the firing bar and a Hall-effectsensor or indirectly by a current draw of the motor, an encoder coupledto the shaft of the motor, and/or any combination thereof.

For the example graph 5950, the curve 5954 shows the knife velocity Vincreasing from zero at time t=0 to a substantially maximum velocity V1while the knife advances from its fully retracted position through zone1 and into zone 2 of the firing motion. Once the substantially maximumvelocity V1 is reached in zone 2, the knife continues to advance in zone2 and zone 3 until a trigger, threshold and/or event prompts the controlalgorithm to automatically change the firing motion. In this case, asshown in the curve 5952, the firing force F reaches or exceeds apredetermined threshold (the firing force value Fcrit) at the time t1,thereby causing the controller to signal the motor controller to stopthe rotation of the motor(s) which drive the knife of the surgicalinstrument 5900, thereby causing the knife velocity to go from the knifevelocity V1 to zero as shown in the curve 5954. When the controllersignals for the advancement of the knife to stop, the controller mayincrement a start/stop counter which was initially set to zero. In otherwords, the start/stop counter is incremented to one to reflect that onestart/stop cycle has occurred in this particular firing motion.

After the advancement of the knife is stopped at the time t1 or shortlythereafter, upon the occurrence of another trigger such as, for example,a predetermined period of time (t2-t1), a drop of the firing force F apredetermined amount, a slope of the firing force signal reaching orexceeding a predetermined threshold, and combinations thereof, thecontroller may signal the motor controller to restart rotation of themotor(s) which drive the knife of the surgical instrument 5900. As shownin the curve 5954, advancement of the knife may be started again at thetime t2 or shortly thereafter.

As shown in the curve 5954, at the time t2 or shortly thereafter, theknife velocity begins at zero and increases as the knife continuesadvancing in zone 3 of the firing motion until another trigger,threshold and/or event prompts the control algorithm to automaticallychange the firing motion. In this case, as shown in the curve 5952, thefiring force F reaches or exceeds a predetermined threshold (the firingforce value Fcrit) at the time t3, thereby causing the controller tosignal the motor controller to stop the rotation of the motor(s) whichdrive the knife of the surgical instrument 5900, thereby causing theknife velocity to go from the knife velocity V2, which is less than theknife velocity V1, to zero. When the controller signals for theadvancement of the knife to stop, the controller may increment thestart/stop counter from 1 to 2 to reflect that two start/stop cycleshave occurred in this particular firing motion.

After the advancement of the knife is stopped at the time t3 or shortlythereafter, upon the occurrence of another trigger such as, for example,a predetermined period of time (t4-t3), a drop of the firing force F apredetermined amount, a slope of the firing force signal reaching orexceeding a predetermined threshold, and combinations thereof, thecontroller may signal the motor controller to restart rotation of themotor(s) which drive the knife of the surgical instrument 5900. As shownin the curve 5954, advancement of the knife may be started again at thetime t4 or shortly thereafter.

As shown in the curve 5954, at the time t4 or shortly thereafter, theknife velocity begins at zero and increases as the knife continuesadvancing in zone 3 of the firing motion until another trigger,threshold and/or event prompts the control algorithm to automaticallychange the firing motion. In this case, as shown in the curve 5952, thefiring force F reaches or exceeds a predetermined threshold (the firingforce value Fcrit) at the time t5, thereby causing the controller tosignal the motor controller to stop the rotation of the motor(s) whichdrive the knife of the surgical instrument 5900, thereby causing theknife velocity to go from the knife velocity V2 to zero. When thecontroller signals for the advancement of the knife to stop, thecontroller may increment the start/stop counter from 2 to 3 to reflectthat three start/stop cycles have occurred in this particular firingmotion.

According to various aspects, after the third start/stop cycle hasoccurred, the controller signals the motor controller to reverse therotation of the motor(s) which drive the knife of the surgicalinstrument 5900, effectively ceasing further advancement of the knifeand returning the knife to its fully retracted position. This is shownconceptually in the curve 5954 as the knife velocity V stopping at zeroat time t5 while the knife is in zone 3 of the firing motion and in thecurve 5952 as the firing force F stopping at zero shortly after time t5while the knife is in zone 3 of the firing motion. In the example graph5950, the three start/stop cycles is deemed to be indicative of asituation where the surgical instrument 5900 has determined there is aninsufficient possibility of completing the firing motion (e.g., due toan obstruction) so the knife is returned to the fully retracted state,thereby allowing the jaws of the surgical instrument 5900 to be openedand removed from the tissue site. According to other aspects, the numberof start/stop cycles deemed to be indicative of a situation where thesurgical instrument 5900 has determined there is an insufficientpossibility of completing the firing motion can be more than three orless than three.

Although the example graph 5950 reflects the control algorithm deemingthere to be an insufficient possibility of a successful firing motionafter the firing force threshold Fcrit was reached or exceeded threeconsecutive times while the knife is in zone 3 of the firing motion, itwill be appreciated that any number of different criteria may beutilized to deem that there is an insufficient possibility of asuccessful firing motion. For example, according to some aspects, thebreaches may be based on a rate of change of a velocity of the knife, ona rate of change of the load, on a rate of change of the firing force,etc., and the deeming may be based on more than three or less than threeconsecutive breaches, on the knife being in zone 3 or another zone whenthe breaches occur, etc.

Furthermore, although the functionality of the control algorithmsdescribed in connection with FIGS. 117, 118A and 118B were described inthe context of the firing motion, it will be appreciated that thecontrol algorithms of the surgical instrument 5900 may also beconfigured to change, adjust or modify the closing motion in a similarmanner. For example, if the closure force reaches or exceeds apredetermined threshold three consecutive times while tissue is beingcompressed between the jaws of the surgical instrument 5900, the controlalgorithms may deem that there is an insufficient possibility of asuccessful closing motion and automatically adjust the closing motion tostop the closing motion and open the jaws of the surgical instrument5900.

In certain aspects, based on the real-time or continuous determinationof the defect density of the staple form, the control algorithms canautomatically make changes to various closing and/or firing parameters(e.g., clamp pressure, speed of firing, timing of a pause in firing,duration of a firing pause, etc.) to affect staple form.

The information obtained from the sensor array can be analyzed bydetermining the defect density at any location along the staple line.The defect density can be analyzed as a running number along theentirety of the staple line. Alternatively, staple line integrity couldbe determined at each opportunity along the length of the staple line.

The defect density can be used to inform the surgeon of possible issuesprior to unclamping the surgical instrument 5900. If certain thresholdsof defect density are encountered, the surgical instrument 5900 canrespond in different ways.

For example, if the detected defect density or rate is above a firstdecision point, the surgical instrument 5900 may slow down the velocityof the closure tube to allow more time for tissue flow and presumablybetter staple form. The detection of malforms (lack of detection of goodform) can also be used to change the closing and/or firing parameters inreal time to result in better staple formation with the remainder of thestaple line. If the detected defect density or defect rate is above asecond decision point, the surgical instrument 5900 may display awarning to the surgeon prior to the unclamping of the jaws of thesurgical instrument 5900, so that the surgeon can be prepared withadditional therapies to treat potential bleeding or stabilize the tissueas appropriate.

While various details have been set forth in the foregoing description,it will be appreciated that the various aspects of the motorizedsurgical instruments may be practiced without these specific details.For example, for conciseness and clarity selected aspects have beenshown in block diagram form rather than in detail. Some portions of thedetailed descriptions provided herein may be presented in terms ofinstructions that operate on data that is stored in a computer memory.Such descriptions and representations are used by those skilled in theart to describe and convey the substance of their work to others skilledin the art. In general, an algorithm refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities which may, though need notnecessarily, take the form of electrical or magnetic signals capable ofbeing stored, transferred, combined, compared, and otherwisemanipulated. It is common usage to refer to these signals as bits,values, elements, symbols, characters, terms, numbers, or the like.These and similar terms may be associated with the appropriate physicalquantities and are merely convenient labels applied to these quantities.

Although various aspects have been described herein, many modifications,variations, substitutions, changes, and equivalents to those aspects maybe implemented and will occur to those skilled in the art. Also, wherematerials are disclosed for certain components, other materials may beused. It is therefore to be understood that the foregoing descriptionand the appended claims are intended to cover all such modifications andvariations as falling within the scope of the disclosed aspects. Thefollowing claims are intended to cover all such modification andvariations.

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware, orany combination thereof can be viewed as being composed of various typesof “electrical circuitry.” Consequently, as used herein “electricalcircuitry” includes, but is not limited to, electrical circuitry havingat least one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a processor configured by a computer program which at least partiallycarries out processes and/or devices described herein), electricalcircuitry forming a memory device (e.g., forms of random access memory),and/or electrical circuitry forming a communications device (e.g., amodem, communications switch, or optical-electrical equipment). Thosehaving skill in the art will recognize that the subject matter describedherein may be implemented in an analog or digital fashion or somecombination thereof.

The foregoing detailed description has set forth various aspects of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In one aspect, severalportions of the subject matter described herein may be implemented viaApplication Specific Integrated Circuits (ASICs), Field ProgrammableGate Arrays (FPGAs), digital signal processors (DSPs), or otherintegrated formats. Those skilled in the art will recognize, however,that some aspects of the aspects disclosed herein, in whole or in part,can be equivalently implemented in integrated circuits, as one or morecomputer programs running on one or more computers (e.g., as one or moreprograms running on one or more computer systems), as one or moreprograms running on one or more processors (e.g., as one or moreprograms running on one or more microprocessors), as firmware, or asvirtually any combination thereof, and that designing the circuitryand/or writing the code for the software and or firmware would be wellwithin the skill of one of skill in the art in light of this disclosure.

In addition, those skilled in the art will appreciate that themechanisms of the subject matter described herein are capable of beingdistributed as a program product in a variety of forms, and that anillustrative aspect of the subject matter described herein appliesregardless of the particular type of signal bearing medium used toactually carry out the distribution. Examples of a signal bearing mediuminclude, but are not limited to, the following: a recordable type mediumsuch as a floppy disk, a hard disk drive, a Compact Disc (CD), a DigitalVideo Disk (DVD), a digital tape, a computer memory, etc.; and atransmission type medium such as a digital and/or an analogcommunication medium (e.g., a fiber optic cable, a waveguide, a wiredcommunications link, a wireless communication link (e.g., transmitter,receiver, transmission logic, reception logic, etc.).

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more aspects has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more aspects were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousaspects and with various modifications as are suited to the particularuse contemplated. It is intended that the claims submitted herewithdefine the overall scope.

1. A surgical instrument, comprising: an elongated channel configured tosupport a staple cartridge; an anvil pivotably connected to theelongated channel; a closure tube mechanically coupled to the anvil; anelectric motor; and a control circuit electrically connected to theelectric motor, wherein the control circuit is configured to change aclosing motion of the surgical instrument based on a combination ofevents.
 2. The surgical instrument of claim 1, wherein the combinationof events comprises damage to the surgical instrument, staple cartridge,loading between the anvil and the staple cartridge, or use conditions.3. The surgical instrument of claim 1, wherein the control circuit isconfigured to determine a level of overstress or over indicated use andeither slow down the firing speed, only allow completion of a currentcycle, fully shutdown the surgical instrument, only complete apredetermined number of additional firings.
 4. The surgical instrumentof claim 1, wherein the surgical instrument is reusable.
 5. The surgicalinstrument of claim 1, wherein the control circuit comprises: at leastone sensor configured to sense a closing force; and a controllerelectrically coupled to the at least one sensor and the electric motor.6. The surgical instrument of claim 1, wherein the control circuit isconfigured to change the closing motion by one of the following based onthe combination of events: ending the closing motion; limiting a maximumvelocity of the closure tube; reducing a velocity of the closure tube;and reversing a direction of movement of the closing tube.
 7. Thesurgical instrument of claim 6, wherein the control circuit isconfigured to ending the closing motion by returning the anvil to afully open position based on the combination of events.
 8. The surgicalinstrument of claim 1, wherein the combination of events comprises aclosing force exceeding a predetermined threshold at different timesduring a closing motion.
 9. The surgical instrument of claim 1, whereinthe combination of events comprises a closing force exceeding apredetermined threshold a predetermined number of times during a closingmotion.
 10. The surgical instrument of claim 1, wherein the combinationof events comprises a slope of a closing force signal exceeding apredetermined threshold a predetermined number of times during a closingmotion.
 11. A medical instrument, comprising: an elongated channelconfigured to support a staple cartridge; an anvil pivotably connectedto the elongated channel; a knife mechanically coupled to the staplecartridge; an electric motor; and a control circuit electricallyconnected to the electric motor, wherein the control circuit isconfigured to change a firing motion of the surgical instrument based ona combination of events.
 12. The surgical instrument of claim 11,wherein the control circuit comprises: at least one sensor configured tosense a firing force; and a controller electrically coupled to the atleast one sensor and the electric motor.
 13. The surgical instrument ofclaim 11, wherein the control circuit is configured to change the firingmotion by one of the following based on the combination of events:ending the firing motion; limiting a maximum velocity of the knife;reducing a velocity of the knife; and reversing a direction of movementof the knife.
 14. The surgical instrument of claim 13, wherein thecontrol circuit is configured to ending the firing motion by returningthe knife to a fully retracted based on the combination of events. 15.The surgical instrument of claim 11, wherein the combination of eventscomprises a firing force exceeding a predetermined threshold atdifferent times during a firing motion.
 16. The surgical instrument ofclaim 11, wherein the combination of events comprises a firing forceexceeding a predetermined threshold a predetermined number of timesduring a firing motion.
 17. The surgical instrument of claim 11, whereinthe combination of events comprises a slope of a firing force signalexceeding a predetermined threshold a predetermined number of timesduring a closing motion.
 18. A surgical instrument, comprising: anelongated channel configured to support a staple cartridge; an anvilpivotably connected to the elongated channel; a closure tubemechanically coupled to the anvil; a knife mechanically coupled to thestaple cartridge; an electric motor; and a control circuit electricallyconnected to the electric motor, wherein the control circuit isconfigured to change at least one of the following based on acombination of events: a closing motion of the surgical instrument; anda firing motion of the surgical instrument.
 19. The surgical instrumentof claim 18, wherein the control circuit comprises: a sensor configuredto sense a closing force; and a controller electrically coupled to thesensor and the electric motor.
 20. The surgical instrument of claim 18,wherein the control circuit comprises: a first sensor configured tosense a firing force; a second sensor configured to sense a position ofthe knife; and a controller electrically coupled to the first and secondsensors and the electric motor.
 21. (canceled)
 22. (canceled)